K040627, Depuy Orthopaedic, ASR Modular Ace Tabular Cup System

510K SUMMARY - 5 pages
AMENDMENT - 5 pages
CORRESPONDENCE - 34 pages
11
ORIGINAL - 246 pages
45
REVIEWER INFORMATION - 100 pages
291
SUPPLEMENT - 129 pages
391
K0qc6;fl
5 10(k) Summary
NAME OF FIRM:
%,e
r~
AUG 5 - 2005
DePuy Orthopaedics, Inc. PO Box 988

700 Orthopaedics Warsaw, IN 46581-0988
510(k) CONTACT:
Natalie Heck Manager, Regulatory Affairs DePuy ASR~m Modular Acetabular Cup System Femoral Hip Prosthesis Class mI per 21 CFR 888.3330 Hfip Joint metal/metal senilconstrained, with an unceinented acetahular component prosthesis 87 KWA DePuy Pinnacle Metal-on-Metal Acetabular Cup Line (K002883 & K003523)
Wright Medical Metal TRANSCENDArticulation
System (K02 1349)
De~uy Ultima Unipolar Head and Adapter Sleeves
(K965 156)
TRADE NAME: COMMON NAME: CLASSIFICATION:
DEVICE PRODUCT CODE: SUBSTANTIALLY EQUIVALENT DEVICES:
DEVICE DESCRIPTION: The DePuy ASRTm Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter. The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy onepiece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter
kONO6AY
( Cj 2
JC2)
Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12. INDICATIONS FOR USE:
T The DePuy ASR M Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
BASIS OF SUBSTANTIAL EQUIVALENCE: DePuy believes the DePuy ASRTM Modular Acetabular Cup System to be substantially equivalent to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners; the Wright Medical Metal TRANSCEND Articulation System; and the DePuy Ultima Adapter Sleeves based upon the similarities in design, material composition, and intended use/indications for use.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
AUG 5 2005
-
9200 Corporate Boulevard Rockville MD 20850
Ms. Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581-0988 Re: K040627 Trade/Device Name: DePuy ASRTM Modular Acetabular Cup System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Ill Product Code: KWA Dated: May 23, 2005 Received: May 24, 2005 Dear Ms. Heck: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2 - Ms. Natalie Heck This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device , . .. I .. . to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh-industry/support/index.html. Sincerely yours,
Melkerson ar Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Indications for Use
0 5 10(k) Number (if known): Tt Device Name: DePuy ASR Modular Acetabular Cup System Indications for Use: The DePuy ASR Tm Modular Acetabular Cup System is indicated for use in iotathip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Over-The-Counter Use A /O Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page
(PostedNovember 13, 2003)
of 1
(Division Sign-Ofll)
Division of General, Restorative,
and Neurological Devices
510(k) Number
0
0612
*De~uy
Traditional
510(k)
Submission
K040627
DePuy ASR TM Modular Acetabular Cup

System
Request for Additional Information
July 29, 2005
700 ORTI4CPAEDIC DRIVE WARSAW IN a4si1ogaa
*DePuy
510(k): Premarket Notification July 29, 2005
Food and Drug Administration CDRLH/ODE Document Mail Center (HFZ-4OI)
9200 Corporate Blvd.
Rockville, MD 20850
Attn: Ms. Elizabeth Frank
TM Re: Additional Information - K040627 De~ly ASR Modular Acetabular Cup System
UcPu 1 Orthopaedics, Inc. Q0 i0" ~1~

700 @nitopacdic Dave WNrssiW.. nd1,ara 46581-0988
Tei: 4-1(.574) 267 8143
Dear Ms. Frank: to the

DePuy Orthopaedics, Inc. submits the enclosed documentation in duplicate as an addendum by FDA. This
DePuy ASR TM Modular Acetabular Cup System, K040627, currently under review to a
submission is made as an update to information submitted on May 23, 2005 in response request for additional information made by FDA letter request on January 26, 2005.
the
Based upon discussion with you on July 29, 2005 by telephone, DePuy is requesting that from this submission, and
product codes for sizes 57, 59, 61, and 63mm diameters be withdrawn updated
have been removed from the Subject Device listing and the Summary Statement. An in this
product code listing and revised Summary Statement for the subject devices are included additional information.
and this Pursuant to 21 CFR 807.95(c) (3), DePuy considers
our intent to market this device treats it as
510(k) submission to be confidential commercial information and requests that FDA these
such. De~uy has taken precautions to protect the confidentiality of the intent to market government of false information is prohibited devices.
We understand that the submission to the by 18 U.S.C. 1001 and 21 U.S.C. 331(q).
DePuy Orthopaedics acknowledges that the introduction of this device into domestic commercial
and Drug
distribution will be contingent upon written clearance of the 510(k) by the Food Administration.
questions
Thank you in advance for your consideration of our application. If there are any farther fax (574)
regarding this submission, please feel free to contact me via phone (574) 372-7469, 371-4987, or email at nheck &ddus ini com. Regards,
Natalie Heck
Manager, Regulatory Affairs
DePuy Orthopaedics, Inc.
510(k) Summary
NAME OF FIRM: DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedics Warsaw, IN 46581-0988 Natalie Heck Manager, Regulatory Affairs
m DePuy ASRT Modular Acetabular Cup System
510(k) CONTACT: TRADE NAME: COMMON NAME: CLASSIFICATION:
Femoral Hip Prosthesis Class I per 21 CFR 8883330 Hip Joint metal/metal semiconstrained, with an uncemented acetabular component prosthesis 87 KWA DePuy Pinnacle Metal-on-Metal Acetabular Cup Line (K002883 & K003523) Wright Medical Metal TRANSCEND Articulation System (K021349) DePuy Ultima Unipolar Head and Adapter Sleeves (K965156)
DEVICE PRODUCT CODE: SUBSTANTIALLY EQUIVALENT DEVICES:
DEVICE DESCRIPTION: metal acetabular

m The DePuy ASRT Modular Acetabular Cup System is comprised of a one-piece cup, a unipolar femoral head, and a taper sleeve adapter.
alloy one-
The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) 44mm through
piece cup with Porocoat porous coating and is available in outer diameter sizescoating with the 62mm in two-millimeter increments. The outer surface of the cup has a porous to this addition of a hydroxyapatite (HA) coating. There are no separate liner components cups. system, as the liners are integral to the one-piece acetabular alloy and is
The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) The uni
available in a range of diameters from 39 to 55
mm in two-millimeter increments. to DePuy
femoral heads have an internal taper which mates with a taper sleeve adapter specific corresponding one-piece metal
12/14 or 11/13 tapers.
The femoral heads articulate with acetabular cups.
alloy. The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo)
The and +8.5. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, the Ultima Unipolar Head and Adapter
11/13 taper sleeve adapters were previously cleared in
options of +0, +6, and Sleeves 510(k), K(965156 (Jan 24, 1997), and are offered in neck length +12. INDICATIONS FOR USE: use in total hip replacement The .DePuy ASRC"m Modular Acetabular Cup System is indicated for structural damage in the hip procedures for patients suffering severe pain and disability due to arthritis, collagen disorders, joint from rheumatoid arthritis, osteoarthritis, post-traumatic is also indicated for avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis disability due to epiphysis and patients with congenital hip dysplasia, slipped capital femoral techniques. previous fusion, where bone stock is inadequate for other reconstruction BASIS OF SUBSTANTIAL EQUIVALENCE: System to be substantially De~uy believes the DePuy ASRTh Modular Acetabular Cup Cup Linens; the Wright equivalent to the DePuy Pinnacle Metal-on-Metal Acetabular Ultima Adapter Sleeves Medical Metal TRANSCEND Articulation System; and the DePuy intended use/indications for based upon the similarities in design, material composition, and use.
4i
De~uy ASRIm Modular Acetabular System Descritin Hea Uni Fmora Siz 39m
Revised 07/29/2005 Sizing 38.5 OD catalog Number 999800139 Part Number 999890239
-9998902-41 -- 999800141 40.5 00 Uni Femoral Head Size 41mm 9T99890-243 9980~0143 0 Un FmoalHed iz 4mm425 44.5 0099015D9804 Uni Femoral Head Size 45mm -9-99890246 999800146 0D 46mm45.5 Headize -- TniW~emral 99890247 -- 999800147 46.5 00 Uni Eemoral Hea Size 47mma 999890249 999800149 48.5 00 Uni Femoral HedSize 49mm 999890251 999800151 50.50OD Uni Femoral Head Size 51Imm 9499890253 -- 9998001 53 52.5 On Uni Femoral Had Size 53mm -~999890255 -- 999800155 54.490OD Uni Femoral Head Size 55mm 99804 -999803944 44 00 x 38.6 ID Acetabular Shell size 44mm 999800746 06 D99804146 460 -size 46-mm A-,c~etabular Shell 999800748 99804348 48 OD x 42.60 ID Acetabular Shell size 48mm 999800750 999804550 50 OD x 44.60 ID Acetabular Shell size 50mm 999800752 998452 52 00 x 45.60 ID Acetabular Shell size 52mm 99805 -4999804754 54 0D x 46.60 ID Acetabular Shell size 54mm 99005 -- 999804956 56 00 x 48.60 ID Acetabular Shell size 56mm -9-99805158 ~ 4999800758 5800D x 50.60 ID Acetabular Shell size 58mm 999800760 -999805360 60 00 x 52.60 ID Acetabular Shell size 60mm 999800762 9985562 62 00 x 54.60 ID Ihl 62mm size Acetblr 999800312 999800102 +2mm neck Ing, 12/14 taper Taper Sleeve Adapters 12/14 +2 k Taper Sleeve Adap~ters 12/14~+5 ~+5num nec-ng, 12/14 ~taper -999 80 0105 ~ S9998003 15 999800318 Taper Sleeve ~Adapters ~12/14 +8~+8m~mneckI~ng, 12/14 taper -- 999800108
5'
April 28, 2009
Food and Drug Administration Rockville MD 20857
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. WARSAW INDIANA 46581 Re; Premarket Notification Number: K040627 Dear Manufacturer: The Food and Drug Administration (FDA) is currently in the process of evaluating the classification of class III devices that are currently marketed through clearance of a premarket notification (510(k)) submission. These devices were found to be substantially equivalent to a preamendments class III device type for which no date has yet been established for requiring the submission of a premarket approval application (PMA). (A class III preamendments device type is a device type that was legally on the market before May 28, 1976, and that was subsequently classified into class III.) FDA premarket notification (510(k)) records indicate that you received clearance to market a device belonging to one of the class III device types being evaluated. Accordingly, FDA is requesting that you submit specific information, discussed below, to support these classification efforts. These classification efforts will culminate in a decision either to call for a PMA for these class III devices, or to reclassify these devices into Class II (special controls) or Class I (general controls). FDA will reach this decision based on all available and reviewed information pertaining to each device type. For certain device types, classification panel hearings may be held to assist in these efforts. Any future proposed decisions will apply to the device type as a whole, not solely to your individual device. As stated, FDA, in accordance with Section 515(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(i)), is requiring manufacturers who were marketing, or have clearance to market through a 5 10(k) substantial equivalence decision, the class III device types referenced above as of April 9, 2009, to submit certain information. The enclosed Federal Register notice details the specific device types, the requested information, and the submission instructions. You are required to submit this information by August 7, 2009, to: Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD, 20852. Please note that items posted to this docket will be redacted in accordance with the Freedom of Information Act (FOIA) (5 U.S.C. 552), and posted to the docket. To ensure your posted documents are redacted, prior to posting, please denote submissions uploaded to the docket as such by typing the following words in the top of the "General Comments" box: "CONFIDENTIAL MA TERIAL DO NOT POST TO THE WEB AS REQUESTED BY SUBMITTER. STATUS SHOULD BE CONFIDENTIAL."
If you have information showing that you have received this letter in error, or that our records supporting this letter are inaccurate, such that you are relieved ofthe obligation to submit the requested information, please send an explanation of the error, noting your 510(k) number, to: Attn.: 510(k) Staff, 515(i) Submission
Document Mail Center, HFZ401
Center for Devices and Radiological Health
9200 Corporate Boulevard
Rockville, MD, 20850
Please note that in lieu of submitting the above requested information, you may also petition FDA to reclassify the device type in accordance with Section 513(e) of the act (21 U.S.C. 360c(e)) and our regulations found in 21 CFR Part 860. In general, FDA's review of reclassification petitions can be completed more efficiently when manufacturers collaborate and submit a single reclassification petition that includes all relevant and accurate information for the given device type. This collaboration can be organized by contacting other manufacturers of the pertinent device through either a professional association or other affiliation. Additional information or inquiries relevant to this classification mandate can be obtained by referencing the FDA Class m website at: http://www.fda.gov/cdrh/classiii.html. or bY contacting Sarah K. Morabito at (240) 276-3975. Sincerely yours,
Enclosure
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
AUG 5
2005
9200 Corporate Boulevard Rockville MD 20850
Ms. Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581-0988 Re: K040627 Trade/Device Name:
DePuy ASRTM Modular Acetabular Cup System Regulation Number: 21 CFR 888.3330
Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented
acetabular component, prosthesis
Regulatory Class: III
Product Code: KWA
Dated: May 23, 2005
Received: May 24, 2005
Dear Ms. Heck: the device
We have reviewed your Section 510(k) premarket notification of intent to market (for the indications
referenced above and have determined the device is substantially equivalent in interstate for use stated in the enclosure) to legally marketed predicate devices marketed Amendments, or to commerce prior to May 28, 1976, the enactment date of the Medical Device Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the Act.
The
You may, therefore, market the device, subject to the general controls provisions listing of
general controls provisions of the Act include requirements for annual registration, and
devices, good manufacturing practice, labeling, and prohibitions against misbranding adulteration.
or class III (PMA), it
If your device is classified (see above) into either class 11 (Special Controls) your device can
may be subject to such additional controls. Existing major regulations affecting addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898.
In Register.
publish further announcements concerning your device in the Federal does not mean Please be advised that FDA's issuance of a substantial equivalence determination of the Act
that FDA has made a determination that your device complies with other requirements must
You or any Federal statutes and regulations administered by other Federal agencies. not limited to: registration and listing (21
comply with all the Act's requirements, including, but as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR
Page 2 - Ms. Natalie Heck described in your Section 510(k) This letter will allow you to begin marketing your device as of your device to a legally premarket notification. The FDA finding of substantial equivalence device and thus, permits your device marketed predicate device results in a classification for your I, , to proceed to the market. regulation (21 CFR Part 801), please If you desire specific advice for your device on our labeling please note the regulation entitled, contact the Office of Compliance at (240) 276-0210. Also, Part 807.97).
You may obtain "Misbranding by reference to premarket notification" (21CFR Act from the Division of Small
other general information on your responsibilities under the toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at its htnfi. (301) 443-6597 or at its Internet address http:/wwwfov/cdrtr//suport/index Sincerely yours,
Mark
Melkerson
Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Indications for Use

510(k) Number (if known): _h 4 C 2.7 System Device Name: DePuy ASRTM Modular Acetabular Cup Indications for Use:
TM is indicated for use in totaLhip replacement The DePuy ASR Modular Acetabular Cup System due to structural damage in the hip procedures for patients suffering severe pain and disability arthritis, collagen disorders, joint from rheumatoid arthritis, osteoarthritis, post-traumatic prosthesis is also indicated for Use of the avascular necrosis, and nonunion of femoral fractures. femoral epiphysis and disability due to patients with congenital hip dysplasia, slipped capital reconstruction techniques. previous fusion, where bone stock is inadequate for other
Over-The-Counter Use Prescription Use _~. (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
ON ANOTHER PAGE OF
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PageI of 1 (Posted November 13, 2003)
(Division Sgn-O Division of General, Restorative, and Neurological Devices
510(k) Number
0 t<0 ~(
3
4
DEPARTMENT OF HEALTH AND HUA
SERVICESPulcHatSeve
Centet for Devices and Radiological Health
Office of Device Evaluation
Document Mail Center (HFZ-401)
9Z00 Corporate Blvd.
March07, 2005
~~~~~~~Rockville, Maryland
20850
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 WARSAW, IN 46581 ATTN: NATALIE HECK
510(k) Number: K040627

Product:DEUAS
MODULAR
AEAUA SYSTEM
Extended Until: 25-MAY-2005
Based on your recent request, an extension of time has been granted

for you to submit the additional information we requested.
If the additional information is not received by the "Extended Until"
date shown above your premarket notification will be considered
withdrawn.
if you have procedural or policy questions, please contact the
Division of Small Manufacturers International and Consumer Assistance
(DSMICA) at (301) 443-6597 or at their toll-free number (800) 638-2041,
or contact me at (301) 594-1190.
Sincerely yours,
Marjorie Shulman
Supervisory Consumer Safety Officer
Premarket Notification Section
Center for Devices and
Radiological Health
HIl
*DePuy
a company
March 4, 2005 Ms. Beth Frank Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850
DePuy Orthopaedics, Inc. P0 Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581 -0988 USA Tel: 1 (574) 267 8143
Re: K(040627, Request for 90-Day Extension, Deputy ASR- Modular Acetabular Cup System Dear Ms. Frank: DePuy would like to request a 90-day extension to respond to the request for additional information dated January26, 2005, regarding K040627, ASR- h Modular Acetabular Cup System. The information requested requires additional time to complete. Please contact me directly at 574-372-7469, or nheck 'tny~ushnL!m, if you have any questions or need any additional information regarding this request. Sincerely,
Natalie'S. Heck Manager, Regulatory Affairs
CD
DEPARTMENT OF HEALTH &HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 4658 1-0988
JAN 2 6 2005
Re: K040627/SI Trade Name: DePuy ASRT m Modular Acetabular Cup System Dated: December 2, 2004 Received: December 3, 2004 Dear Ms. Heck: We have reviewed your Section 5 10(k) premnarket notification of intent to market the device referenced above. We cannot determine if the device is substantially equivalent to a legally marketed predicate device because you did not adequately respond to the deficiencies listed in our June 3, 2004 letter. To complete the review of your submission, we require you address the following issues: 1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), with diametrical and sizes ranging from 39-63mm. Your predicate clearances of (b) (4) TM Pinnacle Metal-on-Metal Acetabular Cup (K003523, K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM F-1537), with diametrical clearances between (b) (4) (b) (4) (b) (4) and diameters of 28 or 36mm.
(b) (4)
a. In Supplement 1, you referenced a previously submitted (b) (4)

(b) (4)
11/3
Page 2 - Ms. Natalie Heck b. provided in Supplement 1 range from
(b) (4)
c. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System has
(b) (4)
(b) (4) Based on our concerns regarding the (b) (4) , we believe clinical data are necessary to support a new metal-onmetal system. If the clinical data are collected in the US, the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design. (b) (4) devices, 2. Several of the provided test reports were performed using and these results are being used to support the articulation of the large diameter unipolar femoral heads and ASR acetabular cups in the subject submission. In (b) ,
(b) , the (4) assembly. Differences between the (b) will affect the loading of the system, (4) preclinical testing of a(b) (4) that preclinical testing for a total hip system. Therefore the following reports submitted in Supplement 1 are not considered to be applicable to this submission and the original deficiencies referencing these reports remain:
(4) (4) (b) ( ." While b hip systems are evaluated) as an entire (b) (4) ( as well as wear patterns. 4We do not believe can be appropriately )substituted as
Page 3 - Ms. Natalie Heck

(b) (4)
*fn addition, please recognize that the (b) (4) currently
used in this test report is

(b) (4)
(b) (4) 3. In response to Question 5, you have submitted (b) components of this system. As described above, we do (b) (4) (4) not believe preclinical testing of comparable results, due to differences in in vivo loading conditions. Therefore, the (b) (4) original deficiency remains and both testing for (b) . In addition, the provided (b) (4) (b) (4) (4) the acetabular cup does not address our concerns regarding ( .
4.
b ) The proposed acetabular( component is a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating with the addition of DuoFix 4 ) hydroxyapatite (HA) coating on the outer surface. Your previously cleared Pinnacle
metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo superfinished metal liner that assembles into a porous coated, titanium alloy metal shell. We have
(b) (4)
: a.
(b) (4) (b) (4)
b.
(b) (4)
(b) (4)
The deficiencies identified above represent the issues that we believe need to be resolved before our review of your 510(k) submission can be successfully completed. In developing the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i) of the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of your device.
//5-
Page 4
Ms. Natalie Heck
We also considered the burden that may be incurred in your attempt to respond to the deficiencies. We believe that we have considered the least burdensome approach to resolving these issues. If, however, you believe that information is being requested that is not relevant to the regulatory decision or that there is a less burdensome way to resolve the issues, you should follow the procedures outlined in the "A Suggested Approach to at: Resolving Least Burdensome Issues" document. It is available on our Center web page ~~~~~~~~~udnoehr You may not market this device until you have provided adequate information described above and required by 21 CFR 807.87(l), and you have received a letter from FDA allowing you to do so. If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug, and Cosmetic Act (Act). You may, however, distribute this device for investigational purposes to obtain clinical data if needed to establish substantial equivalence. Clinical investigations of this device must be conducted in accordance with the investigational device exemption (IDE) regulations. If the information, or a request for an extension of time, is not received within 30 days, we will consider your premarket notification to be withdrawn and your submission will be deleted from our system. If you submit the requested information after 30 days it will be considered and processed as a new 510O(k); therefore, all information previously submitted must be resubmitted so that your new 5 10(k) is complete. Please note our guidance document entitled, "Guidance for Industry and FDA Staff FDA and Industry Actions on Premarket Notification (510O(k)) Submissions: Effect on FDA Review Clock and Performance Assessment". The purpose of this document is to assist agency staff and the device industry in understanding how various FDA and industry actions that may be taken on 510(k)s should affect the review clock for purposes of meeting the Medical Device User Fee and Modernization Act. You may review this document at M9htmll. i ha~p /~/wwwfda gov/cdrhb/mdutf auidance/ 121 The requested information, or a request for an extension of time, should reference your
above 5 10(k) number and should be submitted in duplicate to:
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
Page 5 - Ms. Natalie Heck If you have any questions concerning the contents of the letter, please contact Ms. Elizabeth Frank at (301) 594-1307, extension 115. If you need information or assistance concerning the IDE regulations, please contact the Division of Small Manufacturers, (301) International and Consumer Assistance at its toll-free number (800) 638-2041
or at 443-6597, or at its Internet address http://www.fda.gov/cdrh/indupex.html.
Sincerely yours,A
j
Celia M. Witten, Ph.D., M.D.
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Ms. Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Re: K040627/S1 Trade Name: DePuy ASR"" Modular Acetabular Cup System Dated: December 2, 2004 Received: December 3, 2004 Dear Ms. Heck: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above. We cannot determine if the device is substantially equivalent to a legally marketed predicate device because you did not adequately respond to the deficiencies listed in our June 3, 2004 letter. To complete the review of your submission, we require you address the following issues: 1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), with diametrical and sizes ranging from 39-63mm. Your predicate clearances of (b) (4) T M Pinnacle Metal-on-Metal Acetabular Cup (K003523, K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM F-1537), with diametrical clearances between (b) (4) (b) (b) (4) and diameters of 28 or 36mm. (4) hip
(b) (4)
a. In Supplement 1, you referenced a previously submitted "(b) (4)

(b) (4)
Page 2 - Ms. Natalie Heck b. The diametrical clearances and tolerances provided in Supplement 1 range from
(b) (4)
c. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System has
(b) (4)
(b) (4) Based on our concerns regarding the (b) (4) , we believe clinical data are necessary to support a new metal-onmetal system. If the clinical data are collected in the US, the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design. ( 2. Several of the provided test reports were performed using b and these results are being used to support the articulation of the large diameter ) unipolar femoral heads and ASR acetabular cups in the subject submission. In( (b) (4) 4 )
can be appropriately substituted as that preclinical testing of a (b) (4) a total hip system. Therefore the following reports submitted in preclinical testing for Supplement 1 are not considered to be applicable to this submission and the original deficiencies referencing these reports remain:
(b) (4)
/10
Page 3 - Ms. Natalie Heck

(b) (4)
*In addition, please recognize that the (b) (4)
used in this test report is

(b) (4)
(b) (4) 3.In response to Question 5, you have submitted (b) (4) data on the (b) (4) of this system. As described above, we do (b) provide not believe preclinical testing of (4) conditions. Therefore, the comparable results, due to differences ini~ivo loading (b) (4) original deficiency remains and both testing for (b) (4) system is na.ee~. In addition, the provided (b) (4) (b) (4) the acetabular cup does not address our concerns regarding ( .
4.
b ) The proposed acetabular ( component is a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating with the addition of DuoFix 4 ) coating on the outer surface. Your previously cleared Pinnacle hydroxyapatite (HA)
metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo superfinished metal liner that assembles into a porous coated, titanium alloy metal shell. We have
( b ) ( 4 )
(b) (4)
a.
(b) (4)
(b) (4)
b.
(b) (4)
(b) (4)
The deficiencies identified above represent the issues that we believe need to be resolved before our review of your 5 10(k) submission can be successfully completed. In developing the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i) of the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of your device.
Ik)
Page 4 - Ms. Natalie Heck We also considered the burden that may be incurred in your attempt to respond to the deficiencies. We believe that we have considered the least burdensome approach to resolving these issues. If, however, you believe that information is being requested that is not relevant to the regulatory decision or that there is a less burdensome way to resolve the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at:
http://www.fdajzov/cdrh/modact/leastburdensome.html
You may not market this device until you have provided adequate information described above and required by 21 CFR 807.87(1), and you have received a letter from FDA allowing you to do so. If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug, and Cosmetic Act (Act). You may, however, distribute this device for investigational purposes to obtain clinical data if needed to establish substantial equivalence. Clinical investigations of this device must be conducted in accordance with the investigational device exemption (IDE) regulations. If the information, or a request for an extension of time, is not received within 30 days, we will consider your premarket notification to be withdrawn and your submission will be deleted from our system. If you submit the requested information after 30 days it will be considered and processed as a new 510(k); therefore, all information previously submitted must be resubmitted so that your new 51 0(k) is complete. Please note our guidance document entitled, "Guidance for Industry and FDA Staff FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment". The purpose of this document is to assist agency staff and the device industry in understanding how various FDA and industry actions that may be taken on 51 0(k)s should affect the review clock for purposes of meeting the Medical Device User Fee and Modernization Act. You may review this document at http://www.fda. gov/cdrh/mdufma/guidance/1219.html. The requested information, or a request for an extension of time, should reference your above 510(k) number and should be submitted in duplicate to: Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
ut:rA1IMENT OF HEALTH AND HUMAN SERVICES
Page 5 - Ms. Natalie Heck If you have any questions concerning the contents of the letter, please contact Ms. Elizabeth Frank at (301) 594-1307, extension 115. If you need information or assistance concerning the IDE regulations, please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301)
443-6597, or at its Internet address http://www.fda. gov/cdrh/industr,//support/index.html.

Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
INRUE
0~l` __.c
_Omc
___
. ~.....
J........ .........
~-,~,,~ --
....................................
Page 6 - Ms. Natalie Heck HFZ-401 DMC HFZ-404 5 10(k) Staff HFZ-410 Division D.O. :1-25-05 f/t:Efrank:tmj
cc:
(2?3
DEPARTMENT OF HEALTh AND HUMAN
SERVICES
Public Health Service Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation
Document Mail Center (ffFZ-401)

Rockville, Maryland 20850
September 01,
2004
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. BOX 988

P.O. WARSAW, IN 46581
ATTN: NATALIE HECK
510(k) Number: K040627

DEPUY ASR
Product:
MODULAR
ACETABULAR CUP
SYSTEM
Extended Until: 03-DEC-2004

withdrawn.
contact the
If you have procedural or policy questions, please Manufacturers International and Consumer Assistance
Division of Small (DSMICA) at (301) 443-6597 or at their toll-free number (800) 638-2041,
Sincerely yours,
Marjorie Shulman
Radiological Health
*DePuy
DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA Tel: +1(574) 267-8143
Aug 31, 2004

Ms. Beth Frank
Rockville, MD 20850
Modular Acetabular Cup Re: K040627, Request for 90-Day Extension, DePuy ASRSystem Dear Ms. Frank: to respond to the request for DePuy would like to request an additional 90-day extension ASR-
Modular Acetabular additional information dated June 3, 2003, regarding K040627, time to complete.
Cup System. The testing information requested requires additional if you have any
Please contact me directly at 574-372-7469, or nheck aLdpyus.ini.com request.
questions or need any additional information regarding this Sincerely,
a S Manager Heck Manager,. Regulatory Affairs
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Center for Devices and

Radiological Health
July 30, 2004
Rockville, Maryland 20850
DEPUY ORTHOPAEDICS, INC.

700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW, IN 46581
ATTN: NATALIE HECK
510(k) Number: K040627

DEPUY ASR
Product: MODULAR
ACETABULAR CUP
SYSTEM
Extended Until: 03-SEP-2004

withdrawn.
If you have procedural or policy questions, please contact the
and Consumer Assistance
Manufacturers International
Division of Small at their toll-free number (800) 638-2041,
at (301) 443-6597 or
(DSMICA) or contact me at (301) 594-1190.
Sincerely yours,
Marjorie Shulman
Radiological Health
Q 3 c
*DePjy
+~ti
4 tn+etnof
company
July 29, 2004 Ms. Beth Frank Food and Drug Administrationm Center for Devices and Radiological Health. office of Device Evaluation Document Mail Center (HFZ-401I) 9200 corporate Blvd. Rockville, MD 20850
DePuy Orthopaedics, Inc. P0 Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581 -0988 USA Tel: 1 (574) 267 8143
~ Re: 1K040627, Request for 30-Day Extension, De~uy ASR- Modular Acetabulaieiup T 0a System Dear Ms. Frank: DePuy would like to request a 30-day extension to respond to the request for additional information dated June 3, 2003, regarding K040627, ASR-
Modular Acetabular Cup System. The testing information requested requires additional time to complete.
Please contact me directly at 574-372-7469, or nheckgidvvusini.cmm if you have any
questions or need any additional information regarding this request.
Sincerely,

Radiological Health
July 06, 2004
Rockville, Maryland
20850
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR.

BOX 988
P.O. WARSAW, IN 46581
ATTN: NATALIE HECK
510(k) Number: K040627

DEPUY ASR
Product: MODULAR
ACETABULAR CUP
SYSTEM
Extended Until: 03-AUG-2004

withdrawn.
Sincerely yours,
Marjorie Shulman
Radiological Health
ODeFuy
DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
July I, 2004US
Ms. Beth Frank Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-40 1) 9200 Corporate Blvd. Rockville, MD 20850
USA
Tel: +1 (574) 267 8143
Re: K040627, Request for 30-Day Extension, DePuy ASR T Modular Acetabular Cup M System Dear Ms. Frank: DePuy would like to request a 30-day extension to respond to the request for additional information dated June 3, 2003, regarding K040627, ASR"" Modular Acetabular Cup System. The information requested requires additional time to research and to assemble, as we need to coordinate with our colleagues in Leeds. Please contact me directly at 574-372-7469, or nheck(a~dpyus.ini.com if you have any questions or need any additional information regarding this request. Sincerely,
Na ieS.ek1

CD
CD
Qc43
DEPARTMENT OF HEALTH &HUMAN SERVICES
Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. P0 Box 988 700 Orthopaedic Drive Warsaw, Indiana 4658 1-0988
'JUN 0 3 2004
Re: K040627 Trade Name: DePuy ASR TMModular Acetabular Cup System Dated: March 8, 2004 Received: March 9, 2004
Dear Ms. Heck: market the device

We have reviewed your Section 510(k) premarket notification of intent to equivalent to a legally
referenced above.
We cannot determine if the device is substantially To complete the
marketed predicate device based solely on the information you provided. review of your submission, we require that you address the following items: I. is composed The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System M Pinnacler" of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), while your predicate CoMetal-on-Metal Acetabular Cup (K003523 & K002883) is composed of Wrought surfaces of Cr-Mo alloy (ASTMFE-1537). The change in material alters the articulating your system creating new safety concerns. Although the Wright Medical alloy TRANSCEND~ Articulation System (K021349) is composed of Cast Co-Cr-Mo were proven to (ASTM F-75), this system had its own clearances and tolerances, which and be safe and effective through their own clinical data. Your diametrical clearances tolerances have not been identified in your submission. cups with In addition, you have proposed 39-63mmn inner diameters for your acetabular 28 and 36 mm matching femoral head diameters. Your Pinnacle predicate only exists in what effect sizes and the Wright TRANSCEND Systemn is 38-54mm. It is unknown While we increasing the diameter to 63fimn will have on the clinical use of the system. testing, we have allowed several small increases in diameters with appropriate bench top are unsure how large is actually safe for clinical use. for All of these design differences can significantly influence the clinical outcomes that we metal-on-metal hip arthroplasty devices. These changes present safety concerns
Page 2 - Natalie Heck
feel cannot be addressed by preclinical testing and must be addressed by clinical data to support a determination of substantial equivalence of your 5 10(k). If the clinical data are collected in the US, the clinical data would need to be collected as part of a FDAapproved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design. 2. that is currently The test reports submitted in Exhibit 4 refer to a (b) (4) (b) (4) under an IDE study with the FDA Please clarify which components of this (b) (4) system are identical to the components in the IDE study and which are unique to this submission. Please complete approriate(b) (4) on the (b) (4) worst-case scenario for the components in this submission or e
(b) (4) (b) (4)
3.
The submission states, "The modularity of using taper sleeve adapters in two taper options allow for a reduced number of fernoral head components while offering various fernoral head offsets and compatibility with multiple fernoral stems." The size of the femoral head can affect the fatigue strength of the femoral stem in vivo. Therefore, we
(b) (4) (b) (4)
the system. Please provide an (b) (4)

(b) (4)
. Please justify your choice for the worst case head/stem construct (e.g., head with largest lateral offset, stem most likely to fail in fatigue). The subject heads use taper sleeve adapters to mate the femoral head to the fernoral stem. The taper sleeve adapter results in a somewhat hollow head design which may be susceptible to additional failure modes (i.e. fatigue fracture involving the cylindrical shaft in which the Sleeve Adapter fits) that a solid head would not encounter. We believe (b) (4) , to assess the strength of the cylindrical sleeve adapter shaft, is necessary to establish the safety and effectiveness of the device. Please provide an
4.
(b) (4)
5.
The test reports included in Exhibit 4 address (b) (4) (b) (4) In addition to(b) (4)
( . Therefore, we believe component b (b) (4) an important )parameter in assessing the the (b) (4) safety and effectiveness of a metal-on-metal hip system. ( Please provide (b) (4) on the system both before and 4 (b) (4) ) after the devices
The deficiencies identified above represent the issues that we believe need to be resolved before our review of your 510(k) submission can be successfully completed. In developing the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i) of the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of your device. We also considered the burden that may be incurred in your attempt to respond to the deficiencies. We believe that we have considered the least burdensome approach to resolving these issues. If, however, you believe that information is being requested that is not relevant to the regulatory decision or that there is a less burdensome way to resolve the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html You may not market this device until you have provided adequate information described above and required by 21 CFR 807.87(1), and you have received a letter from FDA allowing you to do so. If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug, and Cosmetic Act (Act). You may, however, distribute this device for investigational purposes to obtain clinical data if needed to establish substantial equivalence. Clinical investigations of this device must be conducted in accordance with the investigational device exemption (IDE) regulations. If the information, or a request for an extension of time, is not received within 30 days, we will consider your premarket notification to be withdrawn and your submission will be deleted from our system. If you submit the requested information after 30 days it will be considered and processed as a new 510(k); therefore, all information previously submitted must be resubmitted so that your new 510(k) is complete. The requested information, or a request for an extension of time, should reference your above 5 10(k) number and should be submitted in duplicate to: Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
If you have any questions concerning the contents of the letter, please contact Elizabeth Frank at (301) 594-1307, extension 115. If you need information or assistance concerning the IDE regulations, please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours,
C a
Celia M. Witten, Ph.D., M..
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
JUl 0 O 2004
Re: K040627 Trade Name: DePuy ASRTm Modular Acetabular Cup System Dated: March 8, 2004 Received: March 9, 2004
Dear Ms. Heck: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above. We cannot determine if the device is substantially equivalent to a legally marketed predicate device based solely on the information you provided. To complete the review of your submission, we require that you address the following items: 1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), while your predicate Pinnacle Metal-on-Metal Acetabular Cup (K003523 & K002883) is composed of Wrought CoCr-Mo alloy (ASTM F-1537). (b) (4) your system creating new safety concerns. Although the Wright Medical TRANSCEND Articulation System (K021349) is composed of Cast Co-Cr-Mo alloy (ASTM F-75), this system had its own clearances and tolerances, which were proven to be safe and effective through their own clinical data. Your diametrical clearances and tolerances have not been identified in your submission.
T M
In addition, you have proposed 39-63mm inner diameters for your acetabular cups with matching femoral head diameters. Your Pinnacle predicate only exists in 28 and 36 mm sizes and the Wright TRANSCEND System is 38-54mm. It is unknown what effect increasing the diameter to 63mm will have on the clinical use of the system. While we have allowed several small increases in diameters with appropriate bench top testing, we are unsure how large is actually safe for clinical use. All of these design differences can significantly influence the clinical outcomes for metal-on-metal hip arthroplasty devices. These changes present safety concerns that we
feel cannot be addressed by preclinical testing and must be addressed by clinical data to support a determination of substantial equivalence of your 510(k). If the clinical data are collected in the US, the clinical data would need to be collected as part of a FDAapproved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design. 2. that is currently The test reports submitted in Exhibit 4 refer to a (b) (4) (b) (4) Please clarify which components of this under an IDE study with the FDA IDE study and which are identical to the components in the (b) (4) system are (b) (4) on the unique to this submission. Please complete approriate (b) (4) worst-case scenario for the components in this submission or
(b) (4) (b) (4)
3.
The submission states, "The modularity of using taper sleeve adapters in two taper options allow for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems." The size of the femoral head can affect the fatigue strength of the femoral stem in vivo. Therefore, we (b) believe
(4) (b ) (4 (b) (4) ) (b) (4) (b) (4)
(b) (4)
4.
The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The taper sleeve adapter results in a somewhat hollow head design which may be susceptible to additional failure modes (i.e. fatigue fracture involving the cylindrical shaft in which the Sleeve Adapter fits) that a solid head would not encounter. We , to assess the strength of the cylindrical sleeve adapter shaft, is believe (b) (4) necessary to establish the safety and effectiveness of the device. Please provide an
(b) (4)
5.
The test reports included in Exhibit 4 address (b) (4) (b) (4) In addition to (b) (4)
have been known to cause
.),45
(b) (4)
Therefore, we believe is an important parameter in assessing the , safety and effectiveness of a metal-on-metal hip system. Please provide (b) (4) (b) (4) and data on the system both before . after the devices (b) (4)
component (b) (4)
The deficiencies identified above represent the issues that we believe need to be resolved before our review of your 5 10(k) submission can be successfully completed. In developing the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i) of the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of your device. We also considered the burden that may be incurred in your afttempt to respond to the deficiencies. We believe that we have considered the least burdensome approach to resolving these issues. If, however, you believe that information is being requested that is not relevant to the regulatory decision or that there is a less burdensome way to resolve the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at: http ://www.fda.gov/cdrh/modact/leastburdensome html You may not market this device until you have provided adequate information described above and required by 21 CFR 807.87(l), and you have received a letter from FDA allowing you to do so. If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug, and Cosmetic Act (Act). You may, however, distribute this device for investigational purposes to obtain clinical data if needed to establish substantial equivalence. Clinical investigations of this device must be conducted in accordance with the investigational device exemption (IDE) regulations. If the information, or a request for an extension of time, is not received within 30 days, we will consider your premarket notification to be withdrawn and your submission will be deleted from our system. If you submit the requested information after 30 days it will be considered and processed as a new 510(k); therefore, all information previously submitted must be resubmitted so that your new 5 10(k) is complete. The requested information, or a request for an extension of time, should reference your above 5 10(k) number and should be submitted in duplicate to: Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
If you have any questions concerning the contents of the letter, please contact Elizabeth Frank at (301) 594-1307, extension 115. If you need information or assistance concerning the IDE regulations, please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
______________
IIIU\S'I'1
t1I IIY it
IF1114! U \41c
StIRNAMI
\IIT~~~~~~~~~~~
cc:
HFZ-401 DMC HFZ-404 510(k) Staff HFZ- 410 Division D.O. f/t:EFrank:elh:5/27/04

Radiological Health
Evaluation
Office of Device Document Mail Center (HFZ-401) 9200 Corporate Blvd.
March 09, 2004
Rockville, Maryland
20850
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988

WARSAW, IN 46581
ATTN: NATALIE HECK
510(k) Number: K040627

09-MAR-2004
Received:
DEPUY ASR MODULAR
Product: ACETABULAR CUP
SYSTEM
The Food and Drug Administration (FDA), Center for Devices and Radiological
Health (CDRH), has received the Premarket Notification you submitted in
and Cosmetic Act
accordance with Section 510(k) of the Federal Food, Drug,
assigned your submission a
(Act) for the above referenced product. We have unique 510(k) number that is cited above. Please refer prominently to this
510(k) number in any future correspondence that relates to this submission.
We will notify you when the processing of your premarket notification has been
completed or if any additional information is required. YOU MAY NOT PLACE
THIS DEVICE INTO COMMERCIAL DISTRIBUTION UNTIL YOU RECEIVE A LETTER FROM FDA
ALLOWING YOU TO DO SO.
The Act, as amended by the Medical Device User Fee and Modernization Act of 2002
collect user fees for premarket
(MDUFMA)(Public Law 107-250), authorizes FDA to
notification submissions. (For more information on MDUFMA, you may refer to our
website at http://www.fda.gov/oc/mdufma).
Please remember that all correspondence concerning your submission MUST be
sent to the Document Mail Center (DMC)(HFZ-401) at the above letterhead address.
above will not be considered
Correspondence sent to any address other than the one
as part of your official premarket notification submission. Also, please note
the new Blue Book Memorandum regarding Fax and E-mail Policy entitled,
"Fax and E-Mail Communication with Industry about Premarket Files Under Review".
Please refer to this guidance for information on current fax and e-mail
practices at www.fda.gov/cdrh/ode/a02-Ol.html.
You should be familiar with the manual entitled, "Premarket Notification 510(k)
If you
Regulatory Requirements for Medical Devices" available from DSMICA. on how to check
have other procedural or policy questions, or want information on the status of your submission, please contact DSMICA at (301) 443-6597 or
its toll-free number (800) 638-2041, or at their Internet address
http://www.fda.gov/cdrh/dsmamain.html or me at (301)594-1190.
Sincerely yours,
Marjorie Shulman
Medical Device User Fee Cover Sheet - FDA Form 3601

Form Approved:OMB No 0910-0511 Expiration Date: Auust 31,200 DEPARTMENT OF HEALTH AND HUMAN SERVICESILA
Page 1 ofI
OM Stem~ent
MEDICAL DEVICE USER FEE COVER SHEET
~ ~ FOOD~~~ ~~ANDDUYDIITAINMENT iDENTIFICATION NUMBER:
rite the Payment Identification Number on your check.
0'12545
A completed Cover Sheet must accompany each original application or supplement subject to fees. The following actions must betae n to properly submit your application and fee payment: 1. Electronically submit the completed Cover Sheet to the Food and Drug Administration (FDA) before payment is sent. 2. Include a printed copy of this completed Cover Sheet with a check made payable to the Food and Drug Administration. Remember that the Payment Identification Number must be written on the check. 3. Mail Check and Cover Sheet to the US Bank Lock Box, FDA Account, P.O. Box 956733, St. Louis, MO 63195-6733. (Note: Inno case should payment be submitted with the application.) 4. Ifyou prefer to send a check by a courier, the courier may deliver the check and Cover Sheet to: US Bank, Attn: Government Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for courier delivery only. Contact the US Bank at 314-4184821 ifyou have any questions concerning courier delivery.) 5. For Wire Transfer Payment Procedures, please refer to the MDUFMA Fee Payment Instructions at the following URL:
htlp//www fda gov/cdrh/mdufma/faqs htrnl#3a. You are responsible for paying all fees associated with wire transfers.
6. Include a copy of the completed Cover Sheet in volume one of the application when submitting to the FDA at either the CBER or CDRH Document Mail Center. 1. COMPANY NAME AND ADDRESS (Include name, street address, city, state, country, and post office code) DEPUY JOHNSON &JOHNSON 700 ORTHOPAEDIC DRIVE WARSAW, IN46582
1.1 EMPLOYER IDENTIFICATION NUMBER (EIN) 352109957 2. CONTACT NAME
TIFFANY LYON
2.1 E-MAIL ADDRESS
tlyon~dpyus.jnj.com
2.2 TELEPHONE NUMBER (Include Area Code) 574-371-4945 2.3 FACSIMILE (FAX) NUMBER (Include Area Code) 574-371-4987
1_
3. TYPE OF PREMARKET APPLICATION (Select one of the following in each column; ifyou are unsure, please refer to the application descriptions at the following web site: http://www fda.gov/oc/mdufrna Select an application type: Premarket notification (510(k)); except for third party reviews 3.1 Select one
of the types below: Original Application
Supplement Types: [ Efficacy (BLA)
E
E
[
Biologics License Application (BLA) Premarket Approval Application (PMA) Modular PMA
[] Product Development Protocol (PDP) Premarket Report (PMR)
El
El Panel Track (PMA, PMR, PDP)

H Real-Time (PMA, PMR, PDP)
H] 180-day (PMA, PMR, PDP)
~:' NO, I am not a small business
4. ARE YOU A SMALL BUSINESS? (See the instructions for more information on determining this status.)
H] YES, I meet the small business criteria and have submitted the
required qualifying documents to FDA 4.1 If Yes, please enter your Small Business Decision Number:
5. IS THIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCEPTIONS? IF SO, CHECK THE
APPLICABLE EXCEPTION.
The sole purpose of the application isto support This application is the first PMA submitted by a qualified small conditions of use for a pediatric population business, including any affiliates, parents, and partner firms
H]
This biologics application is submitted under section 351 of the Public Health service Act for a product licensed for further manufacturing use only
H]
The application is submitted by a state or federal government entity for a device that is not to be distributed commercially
6. IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH FEES WERE WAIVED DUE TO SOLE USE INA PEDIATRIC POPULATION THAT NOW PROPOSES CONDITION OF USE FOR ANY ADULT POPULATION? (Ifso, the application is subject to the fee that applies for an original premarket approval application (PMA).) DYES 9NO
7. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET APPLICATION (FOR FISCAL YEAR 2004) $3,480.00
Form FDA 3601 (08/2003)
https://fdasfinapp4.fda.gov/CFAPPS/mdufma/coversheet/Index.cfm?fuseactionWfuse
RptCo..
1/7/20
Date of Submission: Section A PMA

Original Submission O Modular Submission o Amendment o Report El Report Amendment
CDRH SUBMISSION COVER SHEET

FDA Document Number:
Type of Submission
PMA Supplement
PDP
510(k) Original Submission: X Traditional 0 Special n Abbreviated n Additional Information: C Traditional U Special
El Abbreviated
0 Report Amendment
0 Regular U Special U Panel Track U 30-day Supplement U 30-day Notice U 135-day Supplement C Real-time Review 0 Amendment to PMA Supplement
U Presubmission Summary U Original PDP

El Notice of intent to start clinical trials U Intention to submit Notice of Completion 0 Notice of Completion C Amendment to POP C Report
0 Pre-IDE mtng. 0 Pre-PMA mtg.

D Pre-PDP ntg. C 180-Day mtg. C other (specify'):
Meeting
Humanitarian Device Exemption U original submission U Original submission 0 Amendment El Amendment U Supplement o Supplement o Report IDE
Class II Exemption
0 Original Submission
U Additional Information
Evaluation of Automatic Class III Designation
Other Submission Describe Submission:
U Original Submission U Additional Information
Section B
Company/Institution Name: DEPUY, INC. Division Name (if applicable): NA Street Address: 700 Orthopatedic Drive City:
Applicant or Sponsor
Establishment registration number.1818910 Phone number (include area code): (574) 371-4905 Fax number (include area code): (574) 371-4987 State/Province: Zip code: Country:
Warsaw
Contact Name: Natalie Heck Contact Title: Manager, Regulatory Attain
IN
46582
United States of America
Contact e-mail address:
nheck~dpyus~jnj.com
Section C
Company/Institution Name: Division name (if applicable) Street Address: City: Contact Name.
Submission Correspondent (if different from above)

Establishment registration number: Phone number (include area code): Fax number (include area code): State/Province: Zi oe: Country
Section Di C New Device
Reason for Submission
PMAPDP, or HDE
C Location Change:
C Manufacturer
C Sterilizer C Packager C Distributor CReport Submission: CAnnual or Periodic El Post Approval Study 0 Adverse Reaction C1 Device Defect C Amendment
CChange in design, component, or specification: C Software O Withdrawal U Color Additive Additional or Expanded Indications C Material Agreement Licensing Specifications 0oOther (specify below)
o o
o Processing Change:
C Manufacturing
C Sterilization C Packaging El Other (specify below)
C Labeling Change:
El Indications C instructions C Perfonmance Characteristics C Shelf Life C Trade Name Cl other (specify below)_
o Response to FDA correspondence:

C3 Request C Request C Request C1 Request
for applicant hold for removal of applicant hold for extension to remove or add manufacturing site
C Change inOwnership CChange in correspondent
C Other Reason (specify): Section D2 Reason for Submission - IDE
Cl New device C Addition of institution C Expansion/extension of study Cl IRB certification C Request hearing C Request waiver Cl Termination of study C] Withdrawal of application Unanticipated adverse effect C Notification of emergency use Compassionate use request C Treatment IDE C Continuing availability request
o o
C Response to FDA letter concerning: Change in: C Conditional approval n Correspondent 0 Deemed approval C Design C Deficient final report C Informed consent C Deficient progress report C Manufacturer 0 Deficient investigator report C Manufacturing process C Disapproval 0 Protocol - feasibility Cl Request extension for time to El Protocol - other respond to FDA CSponsor Cl Request meeting Cl Report Submission:
Dturrent investigator
C Annual progress
C Site waiver limit reached C Final
C Other reason (specify): Section D3 Reason for Submission - 510(k) X New Device Additional or expanded indications reason (specify):
oOther
C Change in technology XChange in design
Cl Change inmaterials 03 Change inmanufacturing process
Section E
Additional Information on 510(k) Submissions Summary of, or statement concerning safety and effectiveness data: X 510(k) summary attached 6 80510(k) statement
Product codes of devices to which substantial equivalence is claimed: KWAK WA WA 3 KWL
510(k) Number I K002883 2 K021349 3 K965156 4 5 6 Section F
Trade of Proprietary or model name I Pinnacle Metal-on-Metal Acetabular Cup Line 2 Transcend Femoral Heads 3 Ultima Unipolar Head and Adapter Sleeves 4 5 6 I DePuy
Manufacturer
2 Wright Medical 3 DePuy 4 5 6
Product Information - Applicable to All Applications
Common or usual name or classification name: Hip Prosthesis Model Number I 9998001391999800163; 999803944/999806370; 9Q9RAifil 0/7O9RAAil OR 2 3 4 5 FDA document numbers of all prior related submissions (regardless of outcome): NONE 2 8 Data included in submission: Section G 3 9 X Laboratory Testing 4 t0 [ Animal Trials 5 1 1 6 12
Trade or proprietary or model name I DePuy ASR Modular Acetabular Cup System 2 3 4 5
[ Human Trials
Product Classification - Applicable to All Applicants Devices Device Class: I c Class I X Class III [ Class II Unclassified
'roduct code: 87KWA ] C.F.R. Section 888.3320 & 888.3330 G Classification Panel: Orthopedic Devices Branch, Division of eneral and Restorative (D GR D).
Indications (from labeling): Unchanged from K002883, see attached
I~~A
Note: Submission of this infonnation does not affect the need to submit a 2891 or 2891IaFDA Document Number: Device Establishment Registration form. Section HManufacturilglPackagiflg/Sterilizatiofl Sites Relating to a Submission salsmnt registration number: Oaontract Sterilizer X Manufacturer El Contract Manufacturer U Repackager/relabeler Establishment registration number: 8010379 Phone number (include area code): +44 (113) 270 0461 FAX number (include area code): +44 (113) 270 4101 State/Province NA Zip code: LSI SD onr nited Kingdom
FD K Original El Add U Deee810379
Company/Institution name: DePuy International, Inc. Division name (if applicable): Street address: St. Anthony's Road City Leeds Contact name: U.S. contact: Natalie Heck Contact title: Manager, Regulatory Affairs X Original elee Ul Add FAEtbihetregistration number (b) (4) rc
0 auatrer
X Contract Sterilizer Manufacturer 0 Repackager/relabeler
Company/Institution Name: (b) (4) Division name (if applicable Street address: ): (b) (4) City: (b) (4) Contact name: (b) (4) State/Province: NA
FEstablishment registration number: (b) (4) Phone number (include area code): (b) (4) FAX number (include area code): (b) (4) Zip code: (b) (4) CutyU(b) (4)
Company/Institution name: Division name (if applicable): Street address: City: Contact name. Contact title:
Establishment registration number: Phone number (include area code): FAX number (include area code): State/Province: Zip code: Cuty
Contact e-mail address:
*De~uy
TRADITIONAL
510(k)
SUBMISSION
DePuy ASRTM Modular Acetabular Cup System
700 Orthopaedic Drive Warsaw, IN 46580
~ Qt
*De~uy
a com~~wpany
510(k) Notification 8 March ,2004 March8, 2004 Food and Drug Administration CDRIVIODE Document Mail Center (HFZ-40 1)
9200 corporate Blvd.
Rockville, MD 20850
SUBJECT: Sse
510(k) Premnarket Notification DePuy ASRTM Modular Acetabular Cup Sse
PO Box 988
700 Orthopaedic Drive Indiana 46581 -0988 ~~~~~~~~~~~~~Warsaw, ~~~~~~~~~~USA
Tl
1(7)2784
Dear Sir/Madam: in duplicate the following.9remarket

Pursuant to 21 CFR 807.81, please find submitted introduce the DePuy ASR
Modular
notification of the intent of DePuy Orthopaedics to These products are reviewed by the
Acetabular Cup System into commercial distribution. and Restorative Devices (DGRD).
orthopedic Devices Branch in the Division of General to be trade secret and We consider technical information stamped "CONFIDENTIAL" 21 CFR Part 20. for disclosure under confidential commercial information, not available of this device into domestic DePuy Oirthopaedics acknowledges that the introduction clearance of the 510(k) by the Food and commercial distribution will be contingent upon written provided in the document is for the Drug Administration. Substantial equivalence information way reflects upon the patentability of the purpose of FDA marketing clearance only; it in no device. please do not hesitate to contact me at If you have any questions regarding this submission, nheck( dpvtus.IflICOm. (574) 372-7469 Phone, (574) 371-4987 Fax, or email Regards,
Natalie Heck
DePuy ASR
T M
Modular Acetabular Cup System
Table of Contents
.............................
Letter C ove r Table of Contents ........................................ aton..... C rtfi ,...............................,.....................,............
A cu ac T r ulan th Indications for Use Statement....................
....
.o.....o.,-...,...................................
.... and A uthful ccuracy Certification .................................................... Tr ...................................
mmary 510(k) Su and Summary................................................ ationClas.....Certification Cicat l Notf i Premarket
..... B . C Per on ......................
Index for 510(knPontactrem.arket Notification *,......................................
Page
..................
6in 8
L Administrative Information ..........................................................................

A. MenufaeturerInformation Person ......................................................................................
ntact B. Co
10..
D. Predicate Device Information .................................................................. 1.

. E. Indications f or d.................................................................................. 1.
De C.Device ...................................................................................
F. Materials.fori ation.1 .....................................................................................
A. Device Description Drawings gineering................................................................................ L. E n 1 ......................................................................................
H. Proposed Labeing H .DeviceDescription 2...17
........................................................... Desc A. Dev ice quption.1
........................................... 13
.
evice B D b. Photographes(Figx 1
Special Controls ................................................................ Compliance w ith IIT. Sterilization & Packaging IV. 14 ...................................................................................
e A. Sterilization 1.
. B. Packaging Informaion............................................................................. ertising ......................................................................
a Adv Labelingnd V. R ory VI. Testing S..1 ...........................................................................
VIi. Substantial Equivalence ...... uivalent Devices ally Eq A. Substanti and Differences Matrix .18....................
Table 1: Similarities Design/Materials of Construction
Indications
1900
..................................................... Devices Table 2: Predicate Equivalence .20...........................................................
B. Basis for Substantial EXHIBITS List of Devices.20..................
1. Engineerng drawings 2. Draft Product Label and Insert 3. Test Reports 4. HA coating/substrate Manufacturing Information.....9...... 5. Predicate Device Information.200.........................
6.
23 ...........................................
...................................
35 51 ......................................
Indications for Use

510(k) Number (if known): Device Name: DePuy ASR Indications for Use: The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
MC&,
Over-The-Counter Use ADO Prescription Use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Page (PostedNovember 13, 2003)
of
Truthful and Accuracy Certification
In accordance with 21 CFR 807.87 (j), I believe to the best of my knowledge, that all the data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.
Nataltieeck Manager, Regulatory Affairs
Date
510(k) Summary
NAME OF FIRM: DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedics Warsaw, IN 46581-0988 Natalie Heck Manager, Regulatory Affairs DePuy ASRTM Modular Acet Femoral Hip Prosthesis Class III per 21 C FR8.3330 Hip Joint metal/metal semiconstrained, w an uncemented acetabular component prost sis 87 KWA ular Cup System
510(k) CONTACT:
TRADE NAME: COMMON NAME: CLASSIFICATION:
DEVICE PRODUCT CODE:
SUBSTANTIALLY
EQUIVALENT DEVICES: nnacle Metal-on-Metal Acetabular Cup DePu 02883 & K003523) Line Wfght Medical Metal TRANSCEND Articulation stem (K021349) ePuy Ultima Unipolar Head and Adapter Sleeves /(K965156)
DEVICE DESCRIPTION: The DePuy ASRTM Modular Acet ular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, ana taper sleeve adapter. The acetabular component i designed as a cobalt-chrome molybdenum (CoCrMo) alloy onepiece cup with Porocoat rous coating and is available in outer diameter sizes 44mm through 70mm in two-millimeter crements. The outer surface of the cup has a porous coating with the addition of a hydroxyan atite (HA) coating. There are no separate liner components to this system, as the liners ar integral to the one-piece acetabular cups. The uni femoral he rdis manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a ra ;e of diameters from 39 to 63 mm in two-millimeter increments. The uni femoral heads ye an internal taper which mates with a taper sleeve adapter specific to DePuy tapers. The femoral heads articulate with corresponding one-piece metal 12/14 or 11/ acetabular c s. The tap sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 114 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/1 taper sleeve adapters were previously cleared in the Ultima Unipolar Head and Adapter Sleyevs 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and
2.
2+4
5 At
INDICATIONS FOR USE: The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replace ent joint procedures for patients suffering severe pain and disability due to structural damage in the disorders, vascular from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen ients with necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated vious fusion, congenital hip dysplasia, slipped capital femoral epiphysis and disability due to where bone stock is inadequate for other reconstruction techniques. BASIS OF SUBSTANTIAL EQUIVALENCE: DePuy believes the DePuy ASR M Modular Acetabular Cup System to e substantially equivalent e Wright Medical Metal to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners; TRANSCEND Articulation System; and the DePuy Ultima Ad ter Sleeves based upon the similarities in design, material composition, and intended use/indic ions for use.
March 8, 2004
PREMARKET NOTIFICATION CLASS HI CERTIFICATION AND SUMMARY (As Required by 21 CFR 807.94)
I certify that, inmy capacity as Manager of Regulatory Affairs at DePuy Orthopaedics, Inc., aJohnson & Johnson company, that I have conducted areasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for metal-on-metal total hip systems. I further certify that I am aware ofthe types of problems to which metal-on-metal total hip systems are susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety or effectiveness problems is complete and accurate.
Natalie
Date
~Q
(Premarket Notification [510(k)] Number) DePuy ASR Modular Acetabular Cup System
SUMMARY OF THE TYPES AND CAUSES OF

SAFETY OR EFFECTIVENESS PROBLEMS
METAL-ON-METAL TOTAL HIP SYSTEMS
Based on the literature summary provided in G960262 for the DePuy Ultima Metal-OnMetal Acetabular Cup System, the most significant complications associated with historical metal-on-metal total hip replacement systems include: * Loosening, possibly related to surgical technique, poor fixation, sub-optimal bearing design resulting in high frictional torque and/or bearing seizure, or sub-optimal range of motion in early designs; * Pain, possibly related to loosening; * Calcar resorption, possibly related to poor early stem designs and not the metal-on metal articulation; Other potential complications, which could be associated with metal-on-metal hip replacement, but have not been conclusively documented clinically include: * Local and systemic reactions to increased metal ion release and metal wear debris, especially a higher incidence of certain site specific cancers; Fretting and corrosion of the implant due to galvanic corrosion between dissimilar metals;
Other types of safety and effectiveness problems that are associated with metal-on-metal hip replacement are those that are associated with all total joint replacements. These include: infection, dislocation, cardiovascular disorders (including venous thrombosis, pulmonary embolism, and myocardial infarction), pneumonia, atelectasis, hematoma, nerve damage, delayed wound healing, reaction to bone cement, metal sensitivity, bone fracture, soft tissue imbalance, failure to relieve pain, failure to restore range of motion and deformity of the joint. In order to reduce the chance of complications with a metal-on-metal hip replacement device, the following conditions, which tend to adversely affect safety and/or effectiveness of any total joint arthroplasty, should be reduced or eliminated: marked osteoporosis with poor bone stock and danger of impaired abutment of implants, systemic and metabolic disorders leading to progressive deterioration of solid bone support for the implant (e.g. cortisone therapies, immunosuppressive therapies), history of general infectious disease (e.g. erysipelas) or local infectious disease, severe deformities leading to impaired anchorage or improper positioning of the implant, tumors of the supporting bone structure, allergic reactions to the implant materials, and tissue reactions to corrosion or wear products.
TRADITIONAL 510(K)
DePuy ASR TM Modular Acetabular Cup System

ADMINISTRATIVE INFORMATION:
A. Manufacturer: DePuy International Limited St. Anthony Road
Leeds West Yorkshire

UK Establishment Registration Number: Contract Sterilizer: LS II 8DT 8010379
(b) (4)
B.
Contact Person:
Natalie Heck Manager, Regulatory Affairs Telephone (574) 372-7469 Fax: (574) 3714939 Email: nheck(aWdvvus~jni.com
C.
Subject Device Information: Proprietary Name: DePuy ASRTM Modular Acetabular Cup System Total Hip Prosthesis Common Name: Regulatory Class & Reference: Class III per 21 CFR 888.3330 Hip Joint metal/metal semiconstrained, with an uncemented acetabular component prosthesis 87 KWA Prosthesis, Hip, Femoral Metal/Metal
Product Code & Name:
10
D.
Predicate Device Information: DePuy Pinnacle Metal-on-Metal Acetabular Cup Line Wright Medical Metal TRANSCEND Articulation System DcPuy Ultirna Unipolar Head and Adapter Sleeves K003523 K002883 K021349 Cleared December 13, 2000 Cleared October 13, 2000 Cleared July l, 2002
K965156
Cleared January 24, 1997
Copies of the 510(k) clearance letters are provided in Exhibit 6.
E.
Indications for Use: The DePuy ASRTM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
F.
Materials:
Acetabular Cup: ASTM F-75 Cast High Carbon Cobalt Chromium Molybdenum Alloy Cast High Carbon Cobalt Chromium Molybdenum Alloy Forged Cobalt Chromium Molybdenum Alloy
Femoral Head:
ASTM F-75
Taper Sleeve Adapter:
ASTM F-799
G.
Engineering Drawings: Engineering drawings are provided in Exhibit 2.
H.
Proposed Labeling: Draft labels and the package insert can be found in Exhibit 3.
11]
[I. A.
DEVICE DESCRIPTION: Device Description:
The acetabular component is designed as a cobalt-chrome molybdenum (Co r o) alloy one-piece cup with PorocoatCR porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shell has a highly polished, superfinished internal bearing surface, and is available with outer diameter sizes 44mm through 70mm in two-millimeter increments. The shell component uses the same Porocoat process used for the predicate device (K002883 & K003523). There is no separate liner component to this system, as it is a one-piece acetabular shell used with a unipolar femoral head and a taper sleeve adapter. Porocoat' porous coating has been fully characterized in previous PN4A and 510(k) submissions (e.g., P820024 AMIL, and K030979 Solution System). Below is a summary of the properties of the Porocoat; porous coating:
(b) (4)
The outer surface of the cup has the addition of a (b) (4) hydroxyapatite (HA) coating. Characteristics of the HA coating on the CoCrMo Porocoat substrate are found in (b) (4) (b) (4) (see contractor reference letter and DePuy raw material specification provided in Exhibit
5). The HA material conforms to ASTM Ft 1185-88 for hydroxyapatite (Ca 5 (P04)30H) ceramic.
The uni femoral head is manufactured from cast high carbon cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 63mm in two-millimeter increments. All of the uni femoral heads have an internal taper which mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11113 tapers corresponding to the external tapers on DePuy femoral stems. The femoral heads have a highly polished, superfinished exterior bearing surface, and articulate with corresponding one-piece metal acetabular cups. (See representative device photographs). The ASR 12/14 taper sleeve adapters are manufactured from forged cobalt-chrome molybdenum (CoCrMo) alloy. The 12/114 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/ 13 taper sleeve adapters are manufactured from wrought CoCrMo alloy and were previously cleared in the Ultima Unipolar Head and Sleeve 510(k), K965 156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and +12.
12
B.
Device Photonahs:
Fig 1: ASR One-piece Cup, sample Unipolar Femnoral Head & ASR Sleeve Adapter
Fig 2: Assembled Components Shown with S-ROM stem
Fig 3: Exploded Components Shown with S-ROM stem
'3
III.
COM'IPIAAN(E WITH SPECIAL CONTROLS:
Sections 513 anti 514 of The Act, as amended under the Safe Medical Devices Act of 1990, do apply to this type of device, but a performance standard has not yet been promulgated. Further, DePuy is not aware of any requirements for postmarket surveillance or other special controls for this device at this time. IV. A. STERILIZATION AND PACKAGING: STERILIZATION METHOD:
(b) (4)
The subject devices are supplied packaged and sterilized by exposure to (b) (4) The sterilization method has been validated by using (b) (4)
(b) (4)
* * * B.
No claims are made regarding pyrogenicity.
PACKAGING INFO: The package materials protecting sterility are (b) (4)
(b) (4)
V.
LABELING AND ADVERTISING:
The package insert and draft labels are provided in Exhibit 3.
VI.
(b) (4)
TESTING SUMMARY:
(b) (4) (b) (4)
14
(b) (4)
DePuy Leeds Research Department Report RDR 151/03 is provided in Exhibit 4.

a.......................DI..IBBB.IIBBtB I l BI iiiB m.....Bi.B.iBi.B.i
(b) (4)
DePuy Leeds Research Department Reports RDR 045/03, 143/02, 283/02, 284/02, 043/03, 128/03, and 032/03 are provided in Exhibit 4.
(b) (4)
(b) (4)
(b) (4)
15
DePuy Leeds Research Department Reports RDR 044/03, 307/02, 006/03, 299/02, 037/03, 145/03, 141/03, 082/03 and 065/03 are provided in Exhibit 4.
16
Nil. A.
SUBSTANTIAL EQUIVALENCE: SUBSTANTIALLY EQUIVALENT DEVICES:
Acetabular Shell Component The DePuy ASRTM Modular Acetabular Cup System acetabular component is designed as a cobaltchrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating and is available in outer diameter sizes 44mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There is no separate liner component to this system, as it is a one-piece acetabular shell used with a unipolar femoral head and taper adapter sleeves. The Pinnacle metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo superfinished metal liner that assembles into a porous coated, titanium alloy metal shell. The Pinnacle MOM liner is available in 28 & 36mm inner diameter options, for use with corresponding 28 & 36mm CoCrMo metal femoral heads. The Wright Medical Metal TRANSCEND one-piece acetabular cup is a cast, high carbon CoCrMo alloy. The cup sizes range from 46 through 64mm and accept femoral heads from 36 through 54mm in diameter. The TRANSCEND acetabular cup has a superfinished inner diameter, with a porous coated outer diameter. The subject device shell component uses Porocoat material and process that is used for previously cleared devices (P820024 AML and K030979 Solution System). (b) (4) (b) (4) The interior of the shell is designed to articulate with the subject uni femoral heads. Articulating surfaces of both the uni femoral head and one-piece acetabular cup are superfinished to ensure form tolerance and a fine surface finish. The HA powder used in the plasma spray process, conforms to ASTM Fl 185-88 Hydroxyapatite
(Ca5(PO4) 3OH) ceramic.
Femoral Heads The subject uni femoral heads are substantially equivalent to Wright Medical's TRANSCEND Articulation System. Both are supplied in larger diameter sizes (DePuy: available in 39mm through 63mm; Wright: available in 38mm through 54mm). Both are manufactured from cast high carbon CoCrMo alloys conforming to ASTM specifications and articulate with a one-piece CoCrMo alloy acetabular shell. Articulating surfaces of both the uni femoral head and one-piece acetabular cup are DePuy heads are available in diameters up to super finished to ensure proper tolerances. (b) (4) (b) (4) 63mm, (b) .
(4)
Taper Sleeve Adapters The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem, whereas the Pinnacle MOM and TRANDSCEND Articulation Systems use a range of femoral heads designed with specific internal taper specifications to fit with femoral stem tapers. The modularity of using taper sleeve adapters in two taper options allow for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems. The subject device taper connections are manufactured from forged CoCrMo alloy and are based upon the design used for the adapter sleeves described in the DePuy Ultima Unipolar Adapter Sleeves 510(k). K965156 cleared on Jan 24, 1997.
17
Table 1:
Similarities and Differences Matrix

Proposed DePuy ASR Uni Femnoral Head and Acetabular Cup System
M
DePuy PinnacleT Metal-on-Metal
Acetabular Cup
K003523 & K002883
Wright Medical Metal TRANSCENDI Articulation System K021349
DePuy Ultima Unipolar Adapters K965156
Design/Material: Femoral Heads Material Cast High Carbon Co-Cr-Mo alloy (STr-M [F-75) 39nim-63mm (in 2mm increments) Superfinished surface 12/14 external taper sleeve adapters manufactured from wrought CoCrMo alloy (ASTM F-799) Taper Sleeve Adapters: 12/14 taper: +1.5, +5, +8.5 l 1/13 taper: +0, +6, -12 (see Ultima taper sleeve adapters) Wrought Co-Cr-Mo
alloy (ASTM F-1537)
28mm & 36mm
Superfinished surface
Femoral Heads:
12/14 and 11/13
internal tapers
Cast High Carbon Co-Cr-Mo alloy
(ASTM F-75)
38mm-54mm (in 2mm increments) Superfinished surface Femoral Heads: 12/14 internal taper Cast High Carbon CoCrMo alloy (ASTM F-75) Femoral Heads: 12/14 taper: -3.5, 0, +3.5 N/A
Diameters Articulation Requirements Taper Sleeve Adapters Taper Geometry
N/A N/A I I/] 3 external taper sleeve adapters manufactured from wought CoCrMo alloy (ASTM F 1537) Taper Sleeve 11/13 taper: +0, +6, +12
Taper/ Neck Lengths
28mm Femoral Heads:

12/14 taper: +1.5, +5,
+8.5
11/13 taper: +0, +3, +6
36mm Femoral Heads: 12/14 taper: -2, +1.5,
+5, +8.5, +12
11/13 taper: +0, +3,
6, +9, +12 Metal Liner Wrought CoCrMo
alloy
(ASTM F-1537)
Acetabular Component Material
Low Profile One Piece Shell Cast High Carbon Co-Cr-Mo alloy (ASTM F-75) Porocoat Porous M Coating with DuoFix T HA coating 44m-70mm (in 2mm increments) 39mm-63mm Superfinished surface
Low Profile
One Piece Shell
Cast High Carbon Co-Cr-Mo alloy
(ASTM [-75) Porous coated N/A N/A
OD Coating
N/A
Outer Diameter Inner Diameter Articulation Requirements
48mm-66mm
(in 2mm increments)
28mm & 36mm
Superfinished surface
46mm-64mm (in 2mm increments) 36mm-54mm Superfinished surface
N/A N/A N/A
I8
[able I: Intended Use/Indications for Use:
Similarities and Differences avlatrix (conti ..
Total hip replacement

procedures for patients suffering severe pain and disability, Indicated for rheumatoid arthritis. osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, non-union of femoral fractures. congenital hip dysplasia~ slipped capital epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.
Same
Total hip arthroplastN for reduction or relict of pain and/or improved hip fumnction Indicated for osteoarthritis. avascular necrosis, anikylosis. protrusio acetabuli. painful hp dysplasia. rheumatoid arthritis. correction of functional deformity. and revision procedures where other treatments or devices have failed,
The Ultinma IUipolar Head Adapter Sleeve is indicated for use in conjunction with a trodulair hip femoral stem in partial hip replacement procedures tor patients suffering severe pain and disability due to femoral fractures. avascular necrosis of the femoral head. osteoarthritis, or other abnormalities, where the major pathology affects the femoral head, the acetabular cavity is normal and not deformed or weakened, and acetabular replacement is not required or desireable.
Sterilization:
(b) (4)
Table 2:
Predicate Devices
______
_________
Name
DePuy Pinnacle Metal-onMetal Acetabular Cup Liner
_____ _____ _____ ____A
Material
Metal Liner: Wrought CoCrMo Alloy
STM F-1537
_ _
510(k)
K003523 K002883
_ _ _ _ _
Clearance Date
December 13, 2000 October 13, 2000
_ _ _ _ _ _ _ _
Wright Medical Transcend

Articulation System
Cast High Carbon CoCrMo alloy

ASTM F-75
K02 1349
___________________
July 1, 2002 January 24, 1997

___________
DePuy UltinmaUnipolar Head

and Ad-apter Sleeves
Wrought CoCrMo alloy

ASTM F-1537
K965 156
______
Copies of the above clearance letters are provided at Exhibit 6. B. BASIS OF SUBSTANTIAL EQUIVALENCY:
The basis for substantial equivalence between the proposed DePuy ASR fm Modular Acetabular Cup System, the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners, the Wright Medical Metal TRANSCEND Articulation System, and the DePuy Ultima Unipolar Adapter Sleeves is the similarities in design, material composition, and intended use/indications for use. DePuy believes the DePuy ASRTm Modular Acetabular Cup System to be substantially equivalent to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners (cleared in K(002883 & K00352 3'y the Wright Medical Metal TRANSCEND Articulation System (cleared in K02 1349) and the DePu'g (I Itima Unipolar Adapter Sleeves (cleared in K965 156).
19
EXHIBIT 1
List of Devices
20
DePuy ASRTM Modular Acetabular System Description Uni Femoral Head Size 39mm
Uni Femoral Head Size 41 mm
Uni Femoral Head Size 43mm
Acetabnlar Shell size 44mm
Acetabular Shell size 46mm
Acetabular Shell size 48mm Acetabular Shell size 50mm Acetabular Shell size 52mm Acetabular Shell size 54 Acetabular Shell size 56560xODx Acetabular Shell size 6mm Acetabular Shell si 60mm Acetabular Shel ize62 Acetabular Sh size 64mm e Acetabular hell size 66mm Acetabu Shell size 68mm Acetaular Shell size 70mm Taper leeve Adapters 12/14 +1.5 AeSleeve Adapters 12/14 5 leeve A 12/14 8.5 Sizing 38.5 00 40.5 00 42.5 OD 44.5 45.5 46.5 OD 48.5 00 50.50D999800151 52.5 OD/ 54.49 56.4800D 50.4650D
0.4400
62.43 44 00 x 38.6 ID 4600 x 40.60 1D 48 OD x 42.60 ID 50 00 x 44.60 ID 52 00 x 45.60 ID 54 00 x 46.60 ID 48.60 ID 58OD x 50.60 ID 60 OD x 52.60 ID x 54.600a 64 OD x 56.60 ID 66 OD x 58.60 ID 68 OD x 60.60 ID 70 OD x 62.60 ID 1.5mm neckIng, 12/14 taper 5mm neckIng, 12/14 taper +8.5mm neck6Ing, 12/14 taper m / Catalog Numn 9998001 r Part Number 999890239 999890241 999890243 999890245 999890246 999890247 999890249 999890251 999890253 999890255 999890257 999890259 999890261 999890263 999800744 999800746 999800748 999800750 999800752 999800754 999800756 999800758 999800760 999800762 999800764 999800766 999800768 999800770 999800312 999800315 999800318
9900145 04 999800147 999800149 999800153 999800155 999800157 999800159 999800161 999800163 999803944 999804146 999804348 999804550 999804652 999804754 999804956 999805158 999805360 999805562 999805764 999805966 999806168 999806370 999800102 999800105 999800108
21
Aah se
Compatible Components List The following are a representative sample of taper adapter sleeve and femoral stemn compatible components for the DePuy ASRTh Modular Acetabular System, and should not be taken as a complete listing. Femoral stem compatible components are limited to stems manufactured of Cobalt Chrome Molybdenum alloy or Titanium alloy, and having taper sizes of 11/13 or 12/14. This limitation corresponds to the listed taper sleeve adapter styles manufactured from Cobalt Chrome alloy. Description
Ultima Unipolar Head Adapter Sleeve +Omm Ultima Unipolar Head Adapter Sleeve +6mm Ulitima Unipolar Head Adapter Sleeve +12mmn AML Hip Stem Prodigy Hip Stem Replica Hip Stem Vision Solution Std Summit Porous Hip Stem Trilock Std Hip Stem Endurance Total Hip Stem Luster Total Hip Stem Summit Cemented Hip Stem Uni-Rom Hip Stem
Material
CoCrMo CoCrMo CoCrMo CoCrMo CoCrMo CoCrMo CoCrMo Ti CoCrMo CoCrMO CoCrMo
_________________________ ___________
Taper
11/13 11/13 12/14
__________
Catalog Number
852622 852623 1554-01-105 1520-16-050 1520-17-050 1530-32-000 1530-33-000 1571-02-000 1570-01-070 1012-01-063
____
PartNumber
852621 852622 852623 1554-01-105
______________
510(k)
K965 156 1/24/97 K965 156 1/24/97 K965 156 1/24/97 K012364
1/3852621
~~~10/19/01
K000207 2/04/00 K(934334 12/21/94 K953703
2/01/96
12/14 12/14 12/14 12/14 12/14 12/14 12/14

__________11/2
1520-16-050 1520-17-050 1530-32-000 1530-33-000 1571-02-000

_____ ____ ____
1570-01-070 1012-01-063
___ ____ ___
K001991 8/25/00 K(001982

7/2 6/0 0
___ ___ ____ ___
1521-01-000 1521-80-001 1570-06-080 8-71664733 85-5872 85-5873 85-5874 56-3514 56-3516
152 1-01-000 152 1-80-001 1570-06-080
K(942370 K(983 136

5/9 8
______________________
~~~~~~~~~~~11/
12/14 11/13 1(023453 K(974331
2/06/98
CoCrMo Ti
_________________________
~~~~~~~~~~11/13/
664734 664735
664736 612195 612196
SROMHip Stem
Ti
11/13
K851422
9/18/85
22
EXHIBIT 2
Engineering Drawings
2q3 23
(b) (4)
(b) (4)
~~~~~
~~~
(b) (4)
(b) (4)
~~
~~
(b) (4)
Previously Cleared Device Drawings

(Sample)
3cc
29
(b) (4)
~~~
(b) (4)
(b) (4)
(b) (4)
c/
(b) (4)
EXHIBIT 3
Labels & Package Insert
3o6
35
Draft IFU
Total Hip SystemM DePuy ASR T Modular Acetabular Cup System For Single Use Only Sterilized by gamma irradiation Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. Description T The DePuy ASR M Modular Acetabular Cup System is comprised of a metal acetabular shell, a metal unipolar femoral head, and a metal taper sleeve adapter. The components are part of a modular system for use in total hip replacement. The acetabular component is a metal alloy one-piece cup with an outer surface consisting of a porous coating with the addition of a hydroxyapatite (HA) coating. The acetabular component articulates with interchangeable unipolar heads up to 63mm in diameter.
The taper sleeve adapters are used with the unipolar heads and mate with corresponding femoral stem tapers.
Indications and Usage The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip
replacement procedures for patients suffering
severe pain and disability due to structural
damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis,
collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the
prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital
femoral epiphysis and disability due to previous fusion, where bone stock is inadequate
for other reconstruction techniques.
TM
Porocoat Porous Coated Components

hip
Porocoat porous coated femoral hip stem and metal backed acetabular cup total components are indicated for cementless
use with fixation provided by biological tissue
ingrowth into the porous coating or for cemented use in which the porous coating serves
as a means to augment the fixation of the prosthesis to the bone cement.
Warning: Use only DePuy modular femoral heads with DePuy femoral stems. The taper
size of the femoral head MUST be matched to the taper size of the femoral stem.
Information for Use An instrumentation system, as well as a system of trial components, is available to assure
at
proper fit an alignment of the prosthesis. Correct fit and alignment will reduce stresses should refer to the
interface surfaces to enhance implant fixation. The surgeon appropriate surgical technique manual details on the use of the instrument system and
implantation of the prosthesis.
This manual is available from your local DePuy sales
representative or distributor.
3o
36
Contraindications stock, Use is contraindicated in cases with active or recent joint sepsis, insufficient bone immaturity, or where loss of marked atrophy or deformity in the upper femur, skeletal musculature or neuromuscular disease would render the procedure unjustifiable. Warnings Improper prosthesis selection or alignment, inadequate fixation, use where contraindicated or in patients whose medical, physical, mental or occupational conditions due to will likely result in extreme stresses to the implant may result in premature failure loosening, fracture or wear. Postoperative care is extremely important. The patient should be instructed on the limitations of the device and should be cautioned regarding load load bearing, ranges of motion and activity levels permissible. Early motion and bearing should be carefully monitored. This implant should not be used with other manufactures' components. Use of
during
components other than those recommended could lead to loosening, wear fracture assembly and premature failure.
Precautions open To prevent contamination of this prosthesis, keep free of lint and powders. Do not surface the package until surgery.
Do not place the implant in contact with prepared bone before the final decision to implant has been made.
Even
An implant should never be re-used. Any implant, once used, should be discarded. stress patterns that
though it appears undamaged, it may have small defects and internal may lead to failure.
Likewise, a new implant should be handled carefully to avoid damage that could
compromise the mechanical integrity of the device and cause early failure or loosening.
of
The wear rate of prosthesis contact surfaces is greatly accelerated if loose fragments When
bone cement become detached and act as an abrasive in the bearing surfaces. using bone cement, care should be taken to remove all excess cement from the periphery
of the implant.
the
The highly polished inner diameter of the acetabular shell and outer diameter of surfaces, as this may damage
femoral head should not come into contact with abrasive be clean
the component and affect performance. In addition, all mating surfaces should before assembly to ensure proper seating.
Adverse Effects been
Peripheral neuropathy, deep wound infection, and heterotopic bone formation have been reported
reported following hip replacements. Subclinical nerve damage has also more frequently, often associated with surgical trauma.
Dislocation and subluxation
also
resulting from improper positioning and/or muscle and fibrous tissue laxity may occur, as may loosening and subsequent failure of the total hip prosthesis.
a
Histological reactions have been reported as an apparent response to exposure to foreign material. The actual clinical significance of these reactions is unknown.
Implanted metal alloys release metallic ions into the body.
In situations where bone
cement is not used, higher ion release due to increased surface area of a porous coated
prosthesis is possible. There have been reports of failure of bone to grow into porous surfaces and fix with
components. Shedding or fragmentation of the porous surface has been reported, potential for release of metallic debris into the joint space. Radiolucencies of bone
37
37
of this adjacent to porous surfaces have been noted, although the clinical significance observation is uncertain in many cases. Serious adverse effects may necessitate surgical intervention. Sterility and Handling supplied The components of the DePuyTM ASR Modular Acetabular Cup System are individually packaged and sterile by exposure to gamma irradiation. size has Remove from the package using accepted aseptic technique only after the correct been determined. or broken DO NOT RESTERILIZE and DO NO USE if the package is damaged and sterility may be compromised. of damaging
Components may not resterilized by the hospital because of the possibility contaminating
the articulating and interfacing surfaces of the implant and/or damaging or greater
the porous surface. The care and handling of porous coated implants demands attention because of the increased potential for particulate and microbiological
surface.
contamination. Body fluids, tissues and particulate matter adhere to the beaded Therefore, it is critical to minimize handling of the prosthesis.
as opened
The package should be opened only after the correct size has been determined, packages may not be returned for credit.
Further information is available from your DePuy representative on request.
38
IFU
For Previously Cleared
Ultima Unipolar Taper Sleeve
31/
39
0902-00-701 Rev. B, 11/03

FOR THE PERSONAL ATTENTION OF THE SURGEON AND OPERATING ROOM STAFF ZUR PERSONLICHEN KENNITNISNAHME DURCH DEN OPERIERENDEN CHIRURGEN
UND DAS OPERATIONS-PERSONAL
A LATTENTION PARTICULIERE DU CHIRURGIEN ET DU PERSONNEL DE BLOC OPERATOIRE
ALLATTENZIONE DEL CHIRURGO E DEGLI ASSISTENTI DI SALA OPERATORIA
PARA LA ATENCION PERSONAL DEL CIRUJANO Y DEL PERSONAL DEL QUIROFANO
PARA A ATENQAO PESSOAL DO CIRURGIAO E DO PESSOAL DA SALA DE OPERAQ6ES
FIA THN RPOZflIKH ENHMEPQZH TOY XEIPOYPrOY KAI TOY RPOIOIRIKOY TOY XEIPOYPrEIOY
PERSOONLIJK MEMOVOOR DE CHIRURG EN HET PERSONEEL VAN DE OK
ATT.: KIRURGEN OG OPERATIONSSTUENS PERSONALE PERSONLIGT
FOR ORTOPEDENS OCH OPERATIONSPERSONALENS KANNEDOM
TIEDOKSI LEIKKAAVALLE KIRURGILLE JA LEIKKAUSSALINHENKILOST6LLE
______________________00Ortlopaedir 7 Drime
leuoy Orthopaedics. I nc.
WaAersraw 0 eI.
USA
OPoW IternatIonal Ltd SIAnthonyrted f R Leeds $00 L$ll

Englond
Tel:cli0k 36814t
TI +44L(113 2700461 l FIe +44il13) 272Ide
0902-00-701 Rev. B, 11103
TOTAL HIP PROSTHESIS, SELF-CENTERINGTM HIP PROSTHESIS AND HEMI-HIP PROSTHESIS HOFTTOTALPROTHESE, SELF-CENTERING"' HUFTPROTHESE UND HEMI-HUFTPROTHESE PROTHESETOTALE CE HANCHE, DE LA PROTHESE DE HANCHE SELF-CENTERINGTM ET DE LA PROTHESE PARTIELLE DE HANCHE PROTESITOTALE DELL'ANCA, PROTESI DELLANCA SELF-ENTERINGM E PROTESI PARZIALE DELL'ANCA PROTESIS DE CADERA TOTAL, PROTESIS DE CADERA SELF-CENTERINGTM (AUTOCENTRANTE) Y DE CADERA PARCIAL
PRCTESE TOTAL DAANCA, PRCTESE DAANCA
SELF-CENTERING~m E PROTESE PARCIAL DAANCA
OAIKH nPOGEIH IIXIOY, AYTOKENTPAPIIMENH [POeEIH IIXIOY SELF-CENTERING KAI

T
MEPIKH IPOGEI IZXIOY T TOTALE HEUPPROTHESE, SELF-CENTERING r HEUPPROTIHESE EN HEMIARTROPLASTIEKVOOR DE HEUP KOMPLET HOFTEPROTESE, SELF-CENTERINGTM HOFTEPROTESE HALVHOFTEPROTESE TOTAL H6FTPROTES, SELF-CENTERINGT. HOFTPROTES OCH HALV HOFTPROTES KOKO LONKAN PROTEESI, SELF-CENTERING ' LONKKAPROTEESI JA LONKAN PUOLIPROTEESI
T
INSTRUCTIONS FOR USE

eAUTION: Federal Las (USA) reatrinlc this device0 t sale by or on the order fta physician.
DEVICE DESCRIPTION
TOTALHIP PROSTHESIS A Total Hip P rontdefin in compe..d of indrriduaalypackaged mtetl tereral hie sler. mOdellr metal or ceramic facoal head and 2 piece metal
backed UlIra HPoMoelealar Weight Polyethylen UHM(P}. casrrohi -etal or allUHWP . e or he - ailax oureace the lip 0joi. natural oe
M T
ace abularcorpoertl declird to replace Et
OELF-CENTERING HIP PROSTHESIS A S.lf-Cereteirr Hip Prosthoeis isa hemti-hip componen e consisting- ea rrieanl'icCUp aid an UHMWPE neet and pla a retainina ring lobe stic area wha Denuy ferotal hip trom and modular metal with cheat dimater correepondingto the irinide ball diameter lofh Self- Ceteenn Hip polyethylee trot emplace thre eetoral head erdr eCk in beri-tip replacement. The Sl- Ceniterira Hip prosthesis aaso ased as pad or a -
TotalHipPreOthe.isA hrese ir onjurction rith UHMWPtE a
cart,,, lattcea inside . harin diameterct.I, pordl
to the oalnide diarreter
f IhI metallic cap that in utilized. The UHMWPE inedr is dsigned wit easliding chanrel intrlOkloand crollar; the collar
expands at the ailt eli as it elide over the equaton of ttomodular fernoral head lhe spririgs bak It it orig inal art shape. The metal Sapcompotent then sriap-looks over the UHMWPE ricet as-embly. Trial redaction Is ac-omplihed . with rtel trial caps ard ... whhicS are idertieat ir dimension to the iotplerltable comporerts to be aced HEMI-HIP PROSTHESIS AHemi-Hipprmstheris is -Toprde da f metalenrcraf stemard hod deaiaed replao ther h taraleomor lead td neh n i nemiarthloplartyl. INTENOED USEJINDICATIONO TOTAL HIP PROSTHESIS
Tttal hipartokroplaste isinteeded to prevideinreasied patiert tlbilty ard reduce pair by replacirig damaed lip in articulatn Ie j i
reretheteisevidece et kiertsonlrd boneItc -eatard support h components Total hn replaeer tioiredteat-d ie the ea f n conditionsi Ar deey ardier dinealodloirIII r stecaroeti, erusati arthritic rtremarc Iahriin, or o-raIta lip Clptei. artal I I 2. A SCaltr nerois Ce teeotal head.
ekhe 3 Acate traumatic t lttet ernoral lead or teck
foorate a Failed pr.viou.s.ip surher/ incldirg tointreconrt-uetior irteal Il-ator. erthrod-io h rmiarthrFplaaty runaco replacement atPteplast rtotal hip r eplaceerrt 5b Cedain carer oankyoesis.
T'
Pr
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sbdke oneks nppntdnill fIljd

impl.ntotet onsa
b.i.ur iskttauma.
en metol1nkknorronjoc. ellerqisbo
kd reLktioker eller-aokmuleningnn
tfrnsr ellki,1r "a nlerveoteolS sthleller lossnin I,9

nlrtnetnoragnennll- h 11 vo naceretent perikllr
AIntlairelatiw
Fertnnerirrgevlennvrlsbcrtelnprrlcknr oiler Irebturerscm kan kr~ne internfiei<
4 SkeldorpO blodb~i<-nekane obtenetnore tchfmoralartarl.
eel 11 , ,I ,pnrm veenoenter odei t enfemorerc ebtureton elj n rnee
proleatl isolatered ubuion eller dinloleatton en hbfltedec till f~lid an inkorrekt vol so impleert~onrolk ~ere konlicenatict. inkorre~t posinionering ave kLomponenterron hellen till l a m bet-biler.eklb Il . II eodelappker. 7. rlnnl, ri elier Irn or k tnine Co den oktoella entremiteten. Tldlt pOstnparetiea 1jrnknrlslekdomer jeblusineblodpropp li ven],lungembohinon bjdetinlorbL 2. Feretnrnr onhlell l Iopsom erlknInI 3 Lnr feeneeennrrno g n obhe len at elekte. 4. Subluxerron one llslnbetlon. Sent peetopenatina I Annlrtnergl~ vntnehborlencreaked en tnendrtneth00 muskelepdrneirq, oibtlyetnirtg etherconsiktliginoreopeeatiotorsoagninroogrookoroente. .I -olrrede problem mod do ipnilat erla ell, kbontralateral
bTO oh onbelledeknn enoikondebenl.ngd. fernral medial.ee.ingnob/ellen e ppo mos kelp, ns
3. Feonrsel-ine~ annreolt~bladrktencreakad en trouma eller for coo belastnine. spenielit isenmband med otiltrenklige mrnogderbenmoteriol pod snoredad onteop<:trn. Lenderenten neo~n oidigoreo(perntioneo icteneperatina broatecnbningprocednen reller Oeneenorptilon 4. OBlio 1)rm ennenr
bidno till nedbrnctolno en tinenireennobfrpldiande Ioscnir~aeoeenplarettet. oln n~r Ipnnrerkolanl, rkalkning ellerossifil Itet ken leda till mi.oka
edrliert gtIet corI r-relnett.het. 0. Tranerrtirsbc~ronu Ondot ipnilcnterle knot till fdljd enintranperenin pcciniooerirngeanentreemiteten. ?. SulreuoeeionCnh dicloketion. Kecmplikoti oserens trekoens och ev~ihetedrsd nid eh6rterkrrningOr nartah00renid enirenginke e renininner On nid pnironerperatescnc. inliat tOenenrnorekteneTeennderm[ tet old plecening an eninter ller nidpositicretine onkocmponentena~ sc~nhetrt art enidgsneektepiskt ben nob e odr vnhe e ~] atb~eet ooh/oe~loroosv rihetoatterbhtle tHIltndkligt neonmad. ~rogreo petratconntie. ObadlOtdefnoerlunob bknedor f~r infeetioncer L lososontoll eerih lrrmrrct ken coked tnedtas uppctdnridnersevsonspreoedoner mr LEVEtIANS e orlekl oneoobuloneenl sj~loerectmrnnnhaft nob lnelohbbf beo~skr nok de tsbennponentneoInoeroran indinidneilt cob STERILTOhnpaokede, steniliserae g]encom r~lnin ]. UHMWPE-ketnrsnentercteteeeeners mod aesplesme,etylenooid ellen ganome All. neterni -veb eh born, k best besttrlneer, onlineoppeilt pO ottertdrpenkningensrikeet Toaut komponentorno or fdrpckningen m henederleedo aseptisoko eriere e betote del ent ko}rneke torto eless~1tO~in e Foe nletllknonpeccrnn 1err oent bcmpoeceten, net fnrpaooningee tbrefler re ek aebad eller em dot stehie imple<etene ecrigt rekenens oa n b~edomninetosen vain p~nerket, med orndOenneptebaett~n encode ananodcice. beserst pa monte reneares one sterilJe*mrs innon den implonrelas. iOt ljhetomadnedeost~endoinstnuk0ioner e SKOLJNIMC/PFNGORfING An~ndste~lL rmstepereatnvtten etler fysikelink soloin*snin0eon b16elaognine en inepectetet. Bl~tlaqg under minst hemminater Terko produktent noedelbte. Inspekteen alia prodakter edne otnenilinenir n STERCLICEPING(ren~altkaepneenter} iOmen metealkot~npnene mdctecsterilieres, nar seebliserine en sko en liqonedensebende porometrer, bent one qorant rod sterilitetenind ISALIpb e e
~penennen
Met<ed Anne
CrkeI Fdrmakom
Temperatu' t32 "C
Epeaneelegstid iae
ANMd [Latpuihmn leononorrilinetineepcedon Crtat pO ho0, m~ote pooode eden. Or peoceespaeemertt

mro[smterOls Bet onknitink errponoonrdo oikt
b f onr ~klid into~ntninscteniliserineselotrUstnira serj onlhpnsd.ek~lest ocintf rtieon s experter r~st enileserticontronnesert k 00penonetcrn Oretr~nade
Drettetot nrt ploeesen n~valsore does tieleorlillipre00 epetetbaetbe ekekanno benlyrkee. $nnabrelteerilseri ken~arnvndes oemna tillersti dol oeh speollke sirhuebbonnpromo. OS~l Aqeand inoeCngstentliseoingteer keeramiska tofemerakuler otter prcotsee. Omstentisero into UHMWPE kampnonentr. Aneond into deesa knmponentet oemden sterile ferpenkningen f~nefatlee cane skenad.d
IAYTTOOHJEET
HUOMAUTIJS: USArn Itltttevaltolakn eaj ittaa ndliden cettcleien myycles nien, oelo nhidec hankkiminect an e1littua cain laokonreilie in er muli.e henekitbitteI5000rln mO~r~yksestO. LAITTEEN KUVAUS KOKO LONfKAJO PROTEESI Kobe lackee prectci Inoectennkeitt~iepebatuetemetellieeste reisiloec Innkbaecceete, meduleeniceete menetaliebotoei bkOrboei~tearnii~leen t poontaoje lobe beborleecelteoseuuimolebppliseotoa eenisto IUHMWFE} polpet oelmiseeesstetelibebsiioseineste metctlliranhisteisectake ra$et itreroili~eetoeinultroeueritnelobyyticeat potyeotoniste IUIAMWpEInolmitelelieta Ionbkamnaljnbbo-osiste. joeko on tounr~eilota brkoocaaaan tcnkbanioelenrscenncllieen niocipinrar. T SELF-CENTERING -LONKKApFIOTEESI lrnnkrskittyOleekkbeprnceeien peblen Iockee ca. joke benetnerlotolliseotna kopicre joeult r roei ms pelyeteernistooealeisrtoeLUto upouonsesesa ja muooiseste ridicmkenastaejacston terletites kdnttoo DePnpy-n e reisiteun leckkeesar jaemodeleeneer meteailipotleronee ic~,jiden peon nalbaisija vestcele iekeekiteyoan oenan pelpeteecisoo eleniset n apotusosarc et sisahetkeisiiee, Sitokaytetoon bonsaemaean j reisilso ur0pa01 keelee reeler lenkes keoramisessa. ltcesekebilrpyioernkkprneteesia kdytet~noyr eode 010k oke lonkeec k bokoenacv pret$eeie koyenena$sc pndonsa UHiMWpE valloiseeun toakipinneerbansce,ionbe sisorealkaeisije sta nesteekoytenttnon neettalikepir olksltelkeieije. UHMWPE ecrooelminlettusupotueoo$or cuuceitetlet aott siieaon liobkuoobenooaieen in Unrnees Paulut. Knob~s umi, uann lubiess Iselaenee kebdalta, ken so lioked modunaanserc misilaun peon ebnaaetten yii in paautee~lten siao lkoupe-diceen muetoensae MOetailiesno boppiosa ILobbiutuo ilen o UHMWPEee no vlm~istetoc upeoousea-asenreehmer podle. Sijoill eon osoettemisen bn~keilem'nnen tapaheso mretellisi koebtepeille ja upetoussille, lie joidec bebeneetaaeeenrenevien onionknkee. LONKAN PUOLIPROTEESI l~isoste torisinoctajapallnsta. lotke oren Lookrn peniipnneeei ~onnett eunoet soreitltet boetreonon Isocnellinenneisiluo too ie koala peoli~keen j roeanm ucleibkeebeeessa ooa KAYTT6}TAR KOCTUS/IOOIKAJATIOT KOKOLONKML PROTEESI Kneeo Iocean mecoeasloikkdus reedoon pehtiloae liiekenounder lisaamisekci je blevntnelecennt~ioiki keotaroaila eahieni0tturct loekkeerioel petrieilia, joulea elitntnvoitareveltt olout irt~e on Ian ei 10ke ecei. Kebo lenkan prat eesi en tarekeitetto boptettonoksi iosa ceuteddoisse kItEtoic kinoilion ia/tel nemmeeterot rnid. jocke en aibeopacnt ninelnolebdoc$tmrneooottirn tiioetlulchduc, inelerntasyynineei Ionkon ketitpsbeitio. 2. peicilooc peon nnieseorctor buelie. 3. Akeetti troomon elieentotam neisilson nOpan tel koston martuesa. 4. Aikaisermpi epeonnisotonut letebbeeioelen loikkons, tisoiree biirnctysnomelet iapkietyeslcikkaus. penlittaineen nseooseleibkoee.$ pienoc bonsovn renuoscu$eibksa$ eel ebe ockean k benlanne probed i 0. Tinertin niej*ykietymatapouese porocoatte huskeiSolla pinnoiteella kesitellt sesat Peoeoncal. knoboleslleenir~neninteelen kO-lirttplt reisileountenkkooorniia metailioahvisteiner lorekomoljaero kepin ke eck onar elan on tetkentettou baytett~riksi tilmer sementoirti ia biicnitettooiksi nilin, etto kicot~irer kedebosnknee, keincelioebeieen pinreoieleeceeetoi bkOey~n~eitva serTenteincicken=no, jaible huokobene~ pile toieniiteparca 1i0ata proteesin kiinrnitoyeisoo luusennenooiir. Samantnloidut aeont tsn jo renkbomorjonkepis boon lonkeeneon.t inisee on rneibie'Veir] sceertolteuerne ri neisl kdttd~br on tro~tbet~tt O tetvk~
M
~olekyplinoest
Ei-huoksiSelto pinnoitteetlo poinomnolho uinnitettcilt tai setmetctaiduot k cain Ei-Osekeioerll picceinteelle ktSite~rrn reisiluoenvatreiprotne.sioesr inis~se rnirmie 'vole peniete biinkitpknnt en yeel eseeocoituunberetnclV en toebeitetto b iinenitetnt~ikei pndeticmella lilrnen oernentici ntie boalekyetatvibsi lunaseenenteoirnir kenese. Koetr'atikatta pelentelttet utreisiessnt iKerenreiibolte pinreniestot reiniyreeren preteesin oretareoitettlo keoytettl'oiksi inen somentointia ia biinnit ettonvikei puenslemalle. HUOMtAUThS. ALA KAYrALUUSEMEMNTTIA KERMACIrKALLA OITETUNPROTEES1N PINH KIIPINITtAMISEEN. Moduatorisotretniteoun cit Ja tsnnlkkamalatkkc-eeat euy merelliset tel kereemicer modelaarisel reinilsoue pO~t on tanbeitentu boytett~nibsiBePap:n reisiworciecienbercea. Lcioenokmliebkk boavateenDePo:s eakeiesaisella msetallieahnoietciceste OHMWPE:sIOalmisrelulle,beesmiselle tel m~etalliseallo kekeraan UHMWPOEtOi U o toai neimietetelle iernkbomellakkokuppieeella, jess b~ytetO~n UHMWPeE:lkSt naldnistettua ketraamiste tai metrtliste kecanasa pinteaa lorke ieltohabkicije easle medaleericee teisilnocnee.Ibebaikaisfej. p VAROITUS: K~yti coinOepuly~n o-Ce-Mo- eelkeramiikksatamitstiisla rneleeuac Ipiles yrleoi DCpIWenisllute cornsieneenss. Roisilaun C k p~ietnetarln keor. ON VASTATTAVA rilsiluun oerren kartion kokca. SELF-CENTERING -LONKKAPROTEESI LONKANPUOUPROTEESI JA Self- Cectcmeg-lnonlkkapeeteeeieIa lankee psslipreeteit en terkoiltetio ktoentntosibeipenlittoiseeto lereken maeosleslkbok~Leese~, 10150on nedieteitatiiltoeeOta=tslennllisect a lenkemelinknsle Ia marisivarerm tebkemisebsiICesettomisekeitiirtteeesteinileunur m~rdtooo Petolit toisee lockr~k euoonsleikbaukbernirndikeetoiteil cool:
I Anercl rielilean yeentai koautEc marturee, ieee ei voide koncolle aecetea cijllerrer tel borneosinic~ehllbiienistksellO.
2. Lneken murtemoner m, o~eiepeesl brncello3 vodds ecettn eioClelceen eelrecitessisoise1to kiirnieytdksllo
3. Veti~onrcnet n eisiloenr koeiarlnlusen~ma

4. 5. 0. 7. Reiniloen keulan mor~emile biincittpmetajlomiren. Tiner vnhset~n keenest jar dcisieuu yt boslon mru Peppeuttaoneninnlnnlehdee. bedietos eaic meoiluun icka rekon, lolecislesklEemeino~jkkeea eiar/itee keooata. Taeedinkono bohon liiteey vain relilieue ponbaulo la/tel proksimealicer reisilse, lone neidebc bemto pue~litteicello loekon
iteeeknrtone okkpotecbensest to ybsip~iset meinileun reel en teebeitotte kennetl~aoobo kebe lenkon oente~platiosaeponiloen liikkeouuden lrkeoemiseksia been vhentdmiseks ikervaamoile hinLnittunut leekkanmnet j ur potilaille, coilla riite~s~stitrmetnO noute, or letna to 00vol rueeain koeretee~se ynhnoo UHNIWPE eta nolenieste ~teutkipinnsre kensee, lje cnkanoahlkaiclij castes kayete$toavon mteeattik bopin lllnhbelkeisiieaa Key{t baeklocket pretecein bacoso tenkoinettn kep-t on ec{ivo<slnseureoieeaoileieSEt: FnEitrainrkrcliac In~tel nemmeeternt clod. joeba en elheuttonot ninvtulehdno eneumoottirteen reineetnle ede, nnoelreeume eynnenneerne ci
lonbonbenitysneitlo.
P
pdd
a- Pill.C.U .
,by f.,-
-..... aIF',Iflh fl h
Il I
.d
,IHSq eb
a IIY
Sqp I ,'
-" f ....
U,.
Cementd Components.hi erls Non-Por..us Coaled Pres FlI -rCe-rNeed C.., ...
CAUTJO. DO NOT USE BOINE CEMENT FOR FIXATIONOFA CERAMICCOATED PROSITHESiS. Modular FmRa-I Heads and Acetabular Cottrlpannt A Needyl IltEta or Ieoyl medoloeleso bead Isrob used tooth DaFoy teecra strr c/scralrll. TheII the aceaboUIm nI Is - beaeic suntove 1 I an nsde d -I sith 1l dam rnpvld ...... ia to rhe, outid dIamteio the reodhII lnet-~ld bead that is utiizd.
eeylollndaaitel
SELF-CENTERING HIP PIOSTIESIS AND HEMI-HIP PROSTHESIS
2._FeIcI'rIrdlrpalaI'llr'lcutbbh ptbatcaan otepmbIatIthdaoedIII , .... dteateto 3. -a",aarncet oifte Ipmd oralbeac " 4. 'en-uetlea tenulea ecoes
ICertin bige soboap sen erecorl seab b1Icdturpa Iin eldrly
hitld te
ITerI a I,beuY h
.... ofd tbe Hmetlidoe loot Is tittoe Us inI PI replaaemer ts Iin.iotd Inthe follouing aditinl conF~d
. toa Itins AseunrerlyI pItu and/er." dhIsaldfoirt 1 trom IIIteoartIrIdtiI. ehematid antlaiti, .t cg, truat otbi., IbI hipYO
dypai. 2 . .Failed peius hip sugr picun tposttl. l join etenna-IIII -tinai, artotdesis, slristnolsn or,tota hip relaemnt replacemet otor itb risks associatedWith the oar othpatetdi l .. llImIte d demand regardig acivity and bi, join leding oar be ion.I This, inlde .. b.. l snippled. paients with maltItI igitt uavene tot whom again n ostd loneWARNINGSAND PRECAUTION sect CONTRAIN D CATIDNd
3.IPoo bone qaI-.
sI
asosepooIs
oNt., In the
Iaocn oino, t-"hem 051,1 be soodarable .Fmgtio 1
oI tHe protheis or a
hemi-hip prosthesis.
WARNINGSMID PR.ECAUIONS
CAUTION.
demonstrate t-hat, when aced With, UNIMPEAK euo cups. Itt..u stabildIzd hadsprduc aIr.ttlist loeI mo N.,ne.tia or par-tinute, the tota ameuIt oIT part~iculate Mremanondetemind. Because.I fimhitd clicleat end preehilpinte eNlee, the ....
a tnpagsad trials nampoteetsfrom ditteree manu.aItInErs . or mlanetm theud neee heue tgte *Hip prostheis compo.net shoot -- Iebe rehlmptte. Esee thought.heimlant. appear utda RMa the implant map hav , deveope Iminrscpl impertactpiant htsh W coulI feud to ailure. d
*Guaityfono bone.stock it critica toes reprcIma fIt'aion. of citfmrl -hl aneW. Consilder bone g....n an d oher minth orna .ent tehtl...... esreiatty w~he.tperormint hi srer, ta sea and support the tumora se. .,ot
CAUTION:Ten foilowin conditos iglryo t ocr ic, tend to Impos ecem loadin on the alltested iettemitl tlhemby1plain theI
5 ibeiho .fo tol.I .Y, 0. htbe or,dru addoton

71.Other diailte, as aplicale
CAUTION.TheIoltIn f yrditioro cigfd orRpI neettcdI1 to adsenl attest thefillats of hip PRnptacen'enireplarto
cor tend IMarked osteoporoii or poorbone stok.
2.Metboti d .isorder Orscteic phanmacoegica crestWI,,teadir to progressive . deteriOOi, solid here sappon fo theifeie fc, of .. ,Id .. 3Hstr of genma or goa Isfeoton d. _enr dform-I tie lead to impa d in ire Ilotio
or itprope essItign,nccIItue mplp 2.Teom of the opp...roinspore sorot-ins
0E.MI. Dsblte ot oghr g.itsli.eI., knee sd acctes.d WHEN THESURGEONDEFERMINES THATHIP REPLAICEMENT THE PESOMVEDICAL IS OPTIONAsYAIAPE AND DECIDESTo USE THIS PROSTHESIS APATIENT IN WHO.HASANYOFTHE AOOVE ONOEIONSOR.WHOISShIMPLY YUNG ANDACTISE,IT IS IMERATTIETHAT THNE ENT tE NOTRUCTED PATI ABOUT THE STRENGTHf LIMITATIONS THE MATERIALS OF USED IN THE DEVICEAND FOR IMPLANT tATION HAND THERESULTANT NEEDTO EUc TANTALLY
REOUCE ELIMINATE OR ANYOF THE ASQsE COND ITIONS. LThe gicl, and Phlpetpetlde T.snIemeT. of Ithepatiet must be gnIod out withdoe .I c osidat. II for, ll oisn condItins Mentalatttdes
a n Mt~p iF Th 1 lid Fposiio,fraser, Itor irneplert picaig falr.. t tuciona tfi espTciancy or p Idile hoteicp Is. CI proatet, netceanl pitodlobihd. ImpaII i
gdowen. of 1.The imlants. The
INFORMATION FOR USE THESURGEONSHOULDDISCUSSALL PHYSICALAND MENTALUMITTATIONO PARTICULAR THEPATIENT TOL AND ALLAOPECTSE
THE OF SRER Y AND THE PRCSETHESO .. mWTH THE PATIENT cEEORESURGERY. The disosin should oclde the limitain and posibte.
Th gIne darin Che vpAdii epacren. an tphensl-n tofolo dIII1II sit developmer oI moo hipTh 0 p.M-tsen. tbe tch~ hinstucions.. p-10 -pentv, h oIdia pa.. icularlin regar to at.,co te p...it .hv
baranans1 should.ntba
aeo any bIipprshessbeo
ltdrecvmmesdethatcamponentsatleao
oneoionlergerosd onsaemleraneepe ,O .. 11II
peraseI LhdeterinedphAvalabteatsrgnrat b
potheia.p Be r imprlontIIgIorami amral head the male taper on the,minerlhse IbId be wiped -a atone blood, hone chip or
other11 roig rToial. FoNeigr pateriabetwee IThe-daic head and IThe II f-morat stemh taper may itPod.r pen. seatin .11
heaIdon the
stem. Thi coul aenoth pertanang of thetemra head or H looin mechaismip d the the betas
the fdWoro head urd the tmo~ra stem. Ed not Residff ti ry mmb anes mo Inc~r w.t imlnH iaio. lntpIoIn sefflectionl. -plaonneth or. posit ioningl imlat mop- eatIraaso r
hip reFplace west tea reaI in ineoblity ad/erd dtsiocaio of il ITe jon.
. Prio to oloore th surcl- sit sha.deI I beIhca o-Nant of bane hips. net..aneous Il boneF-d ceen 0500 LHr eoIc her. etc
Foreig
patcLena Tthtmnalplori orIetraie/latie inrunta. reapscone euvesio wear. Rangeonmotiv huLd be thnrasaftt ehhesb Ianm, oe
I
Pastopeatic
IItrfsiadl...rete bath dootopertive care.
paient heso en~ ... Is insrecios and
watnh
is ectrm-l ttg imotant.
Ae...ptod Pasices- heald be lati
-3
edo.
IQ
.1- on the activiiesatia weight beseng witd~ pitw d~ cruthes and iIerwith one UPate huId beoei, a eonisieneere .svesfhr id h .vezvoeoz l Yitr Ioelnsrurnscdnactacii ent Iis h Iar -. d. as'Uu..o.h..M. II ss.
ei macadple isI rnion

.. . Ud.,I
(50I ooiIs, Iob
peptteipto meaplikeot oo'dap
enIl
noo lieoptileille 100~IIP.. kiistts Ipokaise
itedikntsLo kiesiit soelst
ktst-.tioe littovLOL I castos aIjIOl -Cool oodapt ttmlA- (Celpokota AOITUi JA VAROTOIME~ITEE ITi- kL i-lina polilpe blue IkIi CC l nejnls Ilii kuvandenlbhot. pleoomloe I. tt, paene ol,1meo.laao Oo-mTlovesii. K0NTRAI..NDIMTIOT Sootosoat bl -1 k000 1.1eot It lances holo a.psol11iptoteninahl dtaaii IIII jlt en pi- Coline ta Ptemie tlhdus. t , 2Lie- to lil p-lot,.1d ntepmsi, Ocmot cy ... lolhstnliei l~b.keWe a IILLJ ciiihokItvo l-I ... keiseo eaep. el.iiseptn os ... ii5t e cI sic Ltbi I iiolutlle, I eatn oteoseso,.se biegittictinitc mabonpaata aJi. ette ioeclotiryntt ti'll nIciktt , jd-~~~~~~~~~~~~isttilittl-otion IJ11-111111Id'dtL oIl. a da I - a1-- a l-onke novpleid n .. l esosept Cik.II stbmslntatbusstk 1 I bps 1 .s eate hokt sClu lsnhsealotalooot..cn .ataaedyil oneaaia tlb iiI-pe lta j. atnii~ eIta**5 -J, oiite -onC.a-sl Pt COiit-mise Co-insLLIocoloelintet politeps ..I -nanma -aslieaeoeoa I6. KtoistplsetktIaidispitaia Coislikb-ob-csp, op I eid-ln sa-p Ot hosie ko ittn.ttpoit sIt ole koisstt IL IbI . -. I d n elk Lbl bl ci ida Ckcttee oiles kilt U.t~ttEsoeMi otettaCIetI kupien Ia metalIahit,ttetl U.heWpE t salm Lt 1isttieo Cocoic 6,L11 I 170MAA cia eteiIte sic .c tootidekol Cistoitii kpoiond katkei N-00Ccal btet paleotopl d htniipelle hemp koaiolde, eaten 1610 ooat. isisitliteiinltotmienme hd p oaemi.acor oiJ haltkiltpa tsbhae"t, I.Pi. loeeroepa ostel nieo eel bet insi... aie iebb Idbi ilb 5 dsl ... iisot klmaijkksiatoiaslstsJane tiakksto iii ktttostu o
sian
* ikcnjuo1iakiljst hkasalsif....
t-i
calmbitnu .no.isilun pSt a, peilni colds m5c15..ako .
Chinin pithin
kimlitee is osikliiloon kakemus en rjllita
bialagisis
*Ed paIlm ispajo pso,I ImlNtPIMisnios..lrnll keulotelo Wimsnt tl ko....is oi o koskeank5$t5....sssskajsspi. s * enkprtesl si ... k.sks .. sont.aalsudolon sikke ii impisniu.i.nIp.eLI.iitoec~ls lInt .s..... .ll *KtakatIPnsottlIts eels.1kaonsktitkiin.k Keontossai ... kola. ecton pEseoi imptftti. .. 55105 P. KiN..ptatttiont keen ito. an alaso same kuin PysPiil .. tn.. cn. npstn * s .lst.p.e .s .cns .al.m.stN. . I t115,ltt tdct ."teel I5kc5I....... Id L,,4s.lstists ions ceid...t n -amiste oisl... ca-o
pnokindlssissst kllntltyslsn.. La .tficepssist is mAlts tkti halt tos hankie onkin. oisioiLoikkse... teess robleltena.. o suts.si
ILi Call Osou tl poti .an lIIa eii, pain.
2- oomII-e -1 60.l.I I AeI-oIi sea11id 1
7.hdINt saotst lice maccap.

UMAt Sesieasa that ppi tel cdi I.ec S.eiooe 0011 he.oliet Isibat kisesLe pioteodien iiitbses: Wk I *cIp I itcsprpoo Is i telc i. ii-1tdbl k 1,.0 I lepim.1aiblidesmelito otW.,pipimlop dilopteci. .... keipsIpido Lice k1.P.,-t.I. 2.Jlkise.L eietl peieplptothept I de bot elimedetumt, lat pe reeien ejonipo o siciine ta imoasts picetec apl m ootsaleco 5. OpElc..ieooieceiccc.. PePaInc.MILL .-. .d.db.M~i"11.. II 7.I,OytntiteieptoeaeI , d.. mod, locab oTesi ao
-l~id
.~. to
~LIIoooooPeN otitotlciitslsbilci sleope. oei-epte bdoi,
ploct Pi slo oct icil J. (704d(10701 AM-R LtELEE 0TT6 LONKAN KORVAMVA IKCAUSON RAMASLAA(INNALLINEN M LE LAFAI OLSOA AIhTOOCiTO JA PATLM-KAIfLLATM INTICSIA SELLAI PRO SELLE POTiLL JOLL-AOld JOICU YL.LAMAINITUISTA TILOISTA TAI JO"A ON YKOINKORTAIOOOO Ni00 JA AKPIIVINMNONEHOCItOM)AN TIMKEAR E1TT POTILAALLE LAIllEO VALM KERPROTAIN IOTUKdCEPA JA KIINNITYKSESSAKAYTE1FLVAOEN MAATERIML0N OAHCUUDEPOJICTUKSISTA IO SIliP OIOTUVASTAARPEESTAVIhENT.IM R T POISTAAJOKN LLA MAdNITUIPTTILOOT. Potlsan bIteci . alikkaupta pepteavan dseep topedetta o pile ell slpe hoomipo kalkel pLctes .. c..
lIst. potilapsepet...t. oVeniotb1ke potae hood kksMrseekmhhsteospebsodseee kicateis bltici,, cettop hidpPos lickoakace jlO~btitt toipechipto btei tIp'm
L ilallsceloItet .ktsieu tel slielconti hMaidocepa tosetma I shcettas sIIe eteasimplotl tia nopeanpcstipco. Cok~b, Iml
In .s -l e apeotppaaltaampopoe te .c popp.e uItac 1040 IIlop L.ickkeldeice toeneais Ithekl did I111%heebeltdM Id teckellecstoisete.
a. MeidctsIsetcsmpoei
KIPIJRG O.ENN N 0440 LEIN.LSJTA KOSKLPTELTO POTILAAN NANOSA KAIKISTA POTILMLLOE AIhEUTLOISTA Ì,, S STA JA PsYYKKIJIpT RAL.JOIUISISTA IAIKInA LEI KAUKSEENJA PROTEESE JI K h1td LIITFO IST SEIKOISTA. Knokastoluspeon N.oppa 01. niveliT,11Ptaoloapotaipep ihepoca ,I~koaekpe -amaaLd.se.. T-1is -eorekpct Icttt ttsdiaea elnrbil poid. lc entom phicit kchtclttehNcI.idbiioceul pickaesbkbcc,obsNe. Kinoopi ditas -loii.e mi-oct -onccemecepie disiiis kahseocesses col h.t s dtuepetocuhootti-lapel epplocp eslottlo0 Ijipooo-~ lkkaestokiikls.I Tilttccctlst dbol~ctics esetteopt.1.id actc.Co k~llitlic Ikoec-i eanLci T.Nce-ma moT-eepet eploeps, padnnstlisilla kdiruigitl tasitctili opll e, bum . bPtiIL. . _oikkeakssobiksn.
Ottoast Iisos ea tcikaobct.cllI op oseteolll pebioa pIpi kaI.coeoCi seon IlsIti keidlckkeheoelts-id-,noali piePeockolceid.tplcllj. mpsniai Aotemi ia pkcid rpilstt imniani Nltt
I l
aikeae asciamitioo petteso Tome seeptee opkte N esLbat peepI toirnietoan tei1. tisa pe n a. tlileacI Paicslobtsm teei P.seeIo Oucite pinle lCoscelupe oncelcttas kaskesteld melid. Octiadeoe macasIeRop. (II lactose I.acjpostcidbkep. so vIlaCmatNt piute Csk~ikkesotests peeeb ymlillc, kilool typ boitocoapp JsldIet 1500 Coitokosis ..eta osilpattatospipot kiitottosicso., tIslati osn couple, olotPtacicce Ps asettatnilec 0000 ishlee doaeteteteoIi ic WIcle Cktiosesd~ seen iscitudteLiasal solesb impeoid 1 IhOrdyies., Kals WINibkomosoe pneeiSt
eeto
I~kb, tokstsitet~k..N, Lb01I
Lsikkaa~ksotl0lkoss Petl..II. - I Psimalst kotiot,,tmipee phtpap esctis teiallpe kiieic opihccIbevd.aNpieet teleolptphoioteit M.is hoidodipo ees
onepets -N,,c 11Ii I consep cpt toidiste onpelsetuntI .lio hleb clipi,elP INIIIe ik-tanodc Tioni, loPI -ainatvauool i eoTl-55 00 I -oie 10-12 otbbek 1.~b linen.. .. ihs occoats on saeibiv..a Kooks. rmlaoLo Csttik ci toosote -aipdineas rimpEotLokI cliitibso pyotydc. UHMWlPE 'I5 imipteto Recoc plooc pd.a op ati.os.le.. tp , .ltle .jeipol oenockptkonhs htonea se I d sO lobes, js s.l..iltslIte srimpIn I.taogeil is puhtapctps poilsesmaho diiibloscec e arlinlic Joo naoL-k-bstss epiirLlib metkle.k
HAITAVCKTUKETJA KOMPRiK~TIOT II.. Fepei spice pa can mootemcn .lok lityt opeiskoheas VAROITICEIAJA VAROTOIIEN0PITEITAcINIltittaibissickihi 2-thloe teLmIlcpi pntesopos J. I stymicecj. 1c licoy IAsei lIhdec VOROITUKSIA VA.OTOIMENPTEITA mItl JA ,I idi hekkibi 2. ciilucenctepmisooiotaa acrn, ikliosene ,Llkohd..sa VAROFVUKSIA JAVAROTOIMENPITEITAmoottiti oibiih ,LPlcceoeenittec oe almoc11miemloeiltty epic onteassA ROITLUKStAJA.eAOTOMcuoNPtTnEtA melo~ittIo pet1kco hic Vtaco1 1 maetL. P0R~. te.teide. b 0I PcticcepetieoosIot. Lei.ke vol. aIheilo Lb.IVii moo piiloeimoi hcm-pvita. I I .i.. t -tl~i-tblb~lb
~~lo.
ooismaIhIt heiipmpe IdLJI-
I.I
.b ,,i .1II i psolioca-sCt l.ilJ ioittiec1/01
Vdliaikeiosstit.pyop hemosc lest.1.icisi,Toiks- ei.phIeLcLctotil h. I s 0,Lsetiee oi ent ioheamtk b iiSmctlk aba patnbon1
Annint
p-nedi
ihrsett ... im.an. .atciaf oi nt seds tcueo thepnhttf-tfitl.l.ifetme o atIIen...... thy cnt~osholtoefoknatnahIdiwipo"t 0 raph nes.AP besng theolintflanantiplet fjetjorttdLIMWP
NTS AND COMPLICATIONS ADVERS EVE .. ch.ange ipoItio sOthe prostheic cIop tt et ofnnt. talte to thefactor te lste InWARIN'lGSAND PhLGAU~~iDNO.
F 3T., Atjaiott ttetntos lttepooto A0.,Wa or fractr
TINS.
AllD PREOAII ol fe retat- o ration:lse InWARNIINGS I IONS ltd In ,ARING AND,FI~RFCAU
o otre in eaed tollte allrgi tocin, I on, aouaine or potethplies the
lttrtepe..atir
r 7. -tIseeatins t-tolts Illd/a lrplan Iteosnip cause b ,etllro, c-rsoI. 5 -Alt bll cement or"l,11d~ld.
pe IAcetabt"la1Donaion
2FAetrnrsT T.lsatorrtin hsutrfrsta.wochdhradiittIae dIIlII i 3.dTteoiIartefaltr.A
tntttricanno
EanlyP.aste.etie d 2 eoteaatea/o elayed00000 I--'fing 0. Edabannte . Tn. .... rdislc"it
intepeaIo wekeing oft he Ilbi, on~ IIadener maoea tarrolon,putoght-beenIrs iteoolt:ioetpnoetenoIiotld meIatiatt and/on AIto dIrlnlay toretAl1 leagt n t i onsder h psttrln otatrrlha 2.Aggraocfio ofpIIIr . bA -l ,..ED....II atticd e its.D_,i.. ,,
I0.ddeblooto ondi.lopetipp D
i anontrr eIllot Aorger Illo inleedifclts/W inp.-eanI of theeiio. remoial of -T..i Toss and old bon. ems. poitiAI bipedi
lost. ar d t ithof if-etIo. eat. -tt tIme ad/on .eoat, obtaining odegoatatony sapprt In gacro. isaa caid tIoion. of HOW SUPPUtnD
D pcaed, and aplieEd OTbIE.
, componentAat id~ioda E feeto head.ae-abta cap,het. Gentrilo hIp an bato-hip, Fee-oto stemIb. gasb steild w.,ith pImna, Etepes -lda APOD)Or coop.stst may be1 b.U-WR steilize oinsltodIction com hntt oreil meAlace eatoicId : teoeino t,.. afte th corec ritha IIic.aIIseIof1 p noduatiocen-Indreeterda the octet pacag lbel.- Ieato fromthe peiaausocpd
RtNEtNGICLEMItN. STERI1tZA'ON trtI eaeptetson TeeSperatr Time

nEpesare
oIDo LapelOAL)id
MethdCyt
NOTE: T1e oh1 Idfac a
ha ItIsetA, opynopictp00
araeter hopaidatetot
procder mostaecita,,tIsted, 1lttibAfion tet th specifi a it applicable,ccordingto i ceytI... may beI-ondeetd.
-PlanEli re.dcbtt. 1IIpand.I th sotsteetatelproan and it ibil . Ceacei`pemera heads pe..-.se edit nenmid cetees teddEtespettf mautetn CAUTItON: paegieppar detestd.
bi c .otp..eeesteiteIIS thes bor eteattieDo I .otIllCANNOT 1 teesa, gtesle d UHMWPE
.aIa actde V'eetnt ede die Veneede...t darE, -ies Aet.

WISCteN' BtdseezUSAI heoretdie....s GERATEEBESCHAEtBUN.
HO) FTITDTSaDTHESE Ik s-aIe ..t Iotl K oden. f moale HipeOft ec Matc. elemid -tdula.en Fomarkpt oatM hire i.Aoiigtoiprohee aeneet biuo deem .SeI, KceramIbM..aI oder ttakolangeiht (UHMU l baieldete Poletleyfe ape larshhem~i .. _waiteiiiarAatbeekopafs ace metclli hInd d oslettdig aecU.tedf"e die pa Emote, a toad1bhcoaGelenkfiAchteat H0hee-enkeooracheeedralbinzetropack arhalbIT t
SELF'CENTE.tN. m HUFTPOTHESE
.. atIeae alte fetlpaaltEetllOp Il en e e LiHMOEhinrataoDa dpa ide pine tat Cdentrie hatrtaeictsn he"--lhh .ie .mI.tII Durtoee d... end befhf i mit iEro Deco Femer' HDIkactean ainemesdalorap. Matllhgpf bAIcneteestf Kenstotoes I. lnsdchtete der befDneit- Ha-feItAt-t tan PofAethlenencEcrf. em den Fe I -tepcedl cop fee asdewird.de demiT~ AedEdcmece de arrdte U tebiden red Dbet f-IMW E-Tsgtlc. aIngeetII wid, t aiomtnederclmts, dar dem.I. rIei.h.
nmmm
GESRAUCHSANWEISUNG
ESE
HEMt H OFTrrPOTH bootehtee ttAFie H.eoirldt~n ANWENDUN....E.ItETE
E.
H UFTTIOTALPOOTH don htarrpnento 2. g
cautihen Femerkapee ad Schec.holhon Matall.die -a E-oat desb~

-kpcc nemecohTAand.1
prede ic. EdenHftaeaice hal ftiedor.Erlronkunge
bowdl...t..oIenatgeoict
-ioakllee Nebtot dEs enekph Atnos, eiAhrpatk
d.c.Fematopteclbzw.-oceeekelhaltes
atlacnerAFeaher Ikater.ttah 3.i ha~l e phkntrido.itonrFiain . .dc..I .4 P.-~ biilngnnoaoteteerHatpetitfetcletto
keeseacoeo.tpedeyutsaecap allpasiho Op pe-tpot
w E~berttgcteltwid
, beehictaeFemur Hdhschat cad di mI etall oberlaidEtn Azetabutltm-CP-Kmoetebeitt l Incrust, 'porte to.ed -o b~iisloeiece Gewa in die pottee hechichlat amattAIe F-Itaio botet ie dorc doe kit-ckne llhoaect iad fariidia toAti em
amnIEnee wob die por- bchichlong am em,Mbie oar Varstttee der Ftatio den fanohis an dam KnochEneptrteIdiact,
.. NaIn-peeset coated Eineatgketpetete
od,-zoTee-seetece
DKemp
deneeten Ibil
blitimot.,
t Mit her-mi besopicptet pomotcckaftptnoceIied tar diel -etettrIeI Einr1Actioatp SERWENDETWNERDEN.
DASF KEtO KNOCHENEEMENT PROTHESE BESCHICHTETEN ZUR'.IAtON EINER MtT KdEECNtK VORSOCHTt Madutt~rhemcehtttf end Aaetaettekempeeeetee
D Fetnuakoyfee Mate edenbir-si It -5 It den. o.ey Feoutchattkampenenteoataedetw-ne., DosAoetcaete, mutt
-ppae Ei DefaupI. eIIa Ide hetabulu- Cop-Komponeate sac K..aik,
A aproneire eweieuls IotItall ubernltidet UifTMWpeAoetbbee- CIEptIIompttente I KeamIk 0cc MetalLmIt d MEtl oder ,0ltkmme ad JHMW~e pan Depep -Ertta srdee dAIe cc tine ceagech sa UTEMW~E, atrdere, ,odlam- FeosrkApfesectpniclr d.A -machodie dete AtiIedeaceeIm.oser ..ltoeodrhAe. . earpa,,l e Femnkephes MSIDSzt. Die.te't'~ WA....N : Non Dep., tedullne Feesu..epe eec Depe, Ieereetts.e.n .ELr-CENTEStNG HU~iJFPRTHESE.UND HFMt'HuFTPRTHESEN , ParVel-AntainEHifPeoth,,en and Hom,-HiittpAthman sterd yeeIdag ba dEr c ooheeld. Dieyeo- T.luhhttnllesi , betlo.Adote , Hem-FueohrtplacikI. HisaaIca cot ott
boat-lObwgeatgzit beiA. honient Air tolEndet cEldbrAnkege
tel 3U. epakodtanNekoacdeFantrkobte.~ E.diP...adrua enOkeklospatm.32
131 Ita~r-i-I "10 '_oar
CII as C
',inni -ie
Morrnlnlehkk-cusuak
linen FIb kinv
CioCn
l ktonilke ko rmntunen ha
Ilormiseo
yIlktt-
-cikkakca
(001 klotplk toi, IIIkaoj lelnc ahe o og -11 p II, lma Co,, io-hhor IIrroajojenn
clol IWko~lCkrlrurcmtIluko., lijalie k Iormirk-ai ertl.,toteemnse i.kitoekausta c -I,~ k1i
Cikake _ , k11i
4. 401 Ii~kore~nrrI 06 00 ookulaoCekentk nstj k. T 1iiunitkseenn kkikmut,c ...Irahd iie itf , ,niee., ,, 6 koiyhar~or C '~ku,C kchkkeutomjer Cal Potein felono i loha i'ole Ik k-oon Cal T6. Ior.1 ctICr alk lnrhen p10c i-rkk l ,. .l...... lke johiojo -ej kau krencjkcc tp h ktnn t-l ,,er a
OI
I IAC alkkrryrrte lelk dtto
mmclnrerlcuetII no..keikkcun,, Tnaltioja knIlole- -ikkau . knnhij iloncolinia~-c jllkn sIjniirnlkklice luj rnkecm Ill.-jlkoe -rh~ c.1toedu iokio kenkeeriollaiohoianhemtoma
TIM.I IT- i TAPA , - T- III h Rinjluuoorrp... rlno,1 FIoo lokhnnrcaljhekou R C teig-onn .IrtSelf In lon ,l .kanpeirie rento ekit I lpkaiaienerejmIttn ST- lle-1N4 KnI, fi tllknet 1 kenna altr~iI Ionant oe rjlisohunptro l r I UH -ll kWP.nnei-Ilmite eu,t on. -terile h jk knnouI .luteeT ikicii c bdho tli nioer eItt iiueoprn Posnplercoen yooyty nptoatkiiOaruolrn Kil Cll 10cc i 0000 4CC ri eh~ CrCO. I k. ,1 -1II ik I - . ,,-1k I -il K . Vair mrtollc,on o.. naRk I oo eckua ohnoteuen iurili irhnt n ompint ye'alioo ewnC.krr onnir
6
HUUTE~lUOPUHISTUS -. l ... uter1.i- knrerhilp. nt cetro m Fyiolnylist roha- iooi erpicinj F~i-tke iio S roolttc~oici Trinito nknuohecrreseutrrlnijria kkRILOFIiri nlenhiosnth~l hnkcanah P .1l J meoirnirrrilisorrlccrccallerk o tapee r,,,t on Peohetnooi j
Lih jirucnuri kointi Smirouttin 11 .1. ikli o Ior -krhieei n Iaje o din .U.".I Ieton. O
jk
~lk.I
~lii
...
l kl Iohfal ernIII
area lotion. oot r
11 ;I kill~~~ag i.-Ik~~lliLope HU HdIITS:K-lry li i. ,,uini I.jo .k..i. 0300 .. ..U.EloA Kakirr rri ~.loi NtiHoimenitei -eoIeiouu ohinno iiiann kOii u ot.
Klshteloi
nkaet
1 uknlioe
Oa
Interpreaio
of terms and syboI
Ermuteru.ng der Begiff und Signifclo des tIrIe et syblliAT

Significato dIMterii e dci siboll
Sy.,bole
l
'D .
_______DP _____ T
~
t'. Mtra Mateia Qah Qua-titat M~tah'icu Qantit MauiohetCuanhil Materal-Ct~idad Material Q,,rtjdIde
hnterpreain de t6rminos y sfmbolos. lnterpretea.i dos Wermo ElaImblnDWu.I. Eplanveio im 6pea .Oh ,IM OuIppA.. Vierkaring an de ierme en symbolen Forkilnrn til symlboler Ord- och nymbltdklarligr Kfiytettyjen terie 1omerkklen sel"IdseSt
l-
Mcbrid
Kl.ntilt
*- 1 1 1 t** -III., I 1 I . t S *tf 7LIe, -th.neichen, Vrrcndecrgen dennn TdIe ciritihaaisccndtv sIdnnedrpi FuneIiorcddi ncd-nn1 dsIIakacnIarr,1hcl,,i h hccpIrcariian , Sel Ietein Ht cui~1 ,IvIir .... nhdern,idW aiisi finA tinnanzCc iatIoIirarrcinnh h i 1 den de t.l a i P.atieiitnm b I l ,aortdhen In nchiiier-aer, adlinde i ino I In-bIdahdigr Hlulitdlu , II e PeI, ntinerenI IH -i nis nut des Veline [ I .. i. enoraI DonU t 7 en-FiInsc'v lil L1iteciitzecII .. " de-Knoeonere R j, tci Id, I jIleec dci,tinlii I i ncriHO dme I SI"~ D-,I, rIn I III .II,neiii enII ii11U iiirdcchninedeI D I Ciediscidi e I llnc IInnnen Ve-nin Illi IIIi Tarihittieieioto je aiitrnjs Cv nor àlere andliZenand III VeI, -l II li I-Ci .i u aeerrnhe Geec ci Gcivseeh' liinlliihn Arnlnin eIcaieni IIII Annini naI canneine ,
m~un a...
m, t'I M) e I wa - ___ 'A h d
;-"- -
~IririheII
UND0VORSICHTSMASSNAHMEN dh, cineboi
In -i
HemrIllfee,,
Ucmmeneach ech-,e tihinderte
Ptonn mlIt nc nhIche I
2I.
ThTon.
"oor enan -1aselR
Ithe I'~nllon
1ldCI1
D~ld.I.di
dh
d-h~I
.0 IIIned arencei ede Facrhednn I dhi I dI C. deHri-iiehm ind Ik I,nthicin he ,n,Idc -Iirino Anotoe ,i-tar Id lod tin; tam.nlenrId vo tiri -iDone v, r AII aei 7 ien ioIrIII~ t.nId iet~diesi, q a fula~l edele rrdmrdeIAztahI II. neoh i hocariar Ides ndUrl, o H..etab d did etccute Hde.Wne
angenei--ldie..l...I
~nt
,l
diiii,
0b
i~i.
prako~iniceher EidrdhRnan mindie lanetietige bielni.hen Wirkungendie.er Prike1 eiderbekanet. * idtpeaenn-Koeeonnnnd.renidck? re-Iepleber merde. Se mon.. dee. Nimpana ubeocd erehhlnt, dnneego
tcen~asntnlmtanatitr ecinnn find. Sie munso die gleiche ..SBn eie die entcrnhend.n KepAeId.atI.ne. aiwinenmddie * "Itnepanad doee in hoier WoIkeserindel od, me~dilziertweIrde. *Fe "cehechennebcnen .ace Oaeit.tit Iii, dk.ierocieckle -iectio
des Feedersohat.Sr.I not
d.eenen.i.... Beoln. Elieine, act dIe
VORSC ICN DIe falnereN"Eckeaekaenen Stariiee-din ban. ticoi I oddo gIIedIcmezeieIdI fer,dIre eic .cheec cericn bCelN IIon CErneer adl-es. I ioce vatirne IInslee fONtichIeItnhen- Riik, daliJ~ Oder ci d fterear
-. eapi I.Adinn.Ita m.,Ieln UheleoihenPanieten
d
C.Nigneeza 1 Crtree..I
Cu -. dliae DneonemdItrca.nid
7.AineBiidorce, aecteodn
VO6 IHtDeAIIIcl drdnOnnneen.o.aaaocdeeeec
dngecicii cnesc a ie anlnnocidi iair
H7i lnAno inep moto adc ounc -. 2OSC1I Cedeoh . ,ndrne i~deresensh eeianeoeOfadag i doe ronc-iressiner-hn-seoleoecrI dentester .U'd-,.. r,.U.NdieioaetIci c ceilDibtstriies ncillnpie hrpo,-tleeeceeeio c dr 3.A,,crrcnlict.IaIIIomieeadon lolaleictelnelnioec 4.domreDecmidte de rnie Ccei,, Irahoioe Faio aennkree F dIaee den imhidneatec V nIIIhnec. SC. -, T~Umoe de
~aieNtIzgeaceacc.~d
cecadceantceain
6.OIenies Uedm
ok
esilKncenlre
oal
,olneneeleel.
WENOGOP DOFWTOUR DERANCIGHT lOT,DASSFINHLITORSATZ BESIEN MOIZNISCHEN INTERFSSE lt E

DESPATIENTOI UNOD 1ST SlC. SADAZUdNSCHEIDOT.DIESE PROUTHOSO
E11REM 00 PATIRNTONZD VERWENDFEN DER AN CINER DER OFEN AN.EGEBENEN
OOKOApcilINGENO LEIDETE"D` GOPJ131G
UND AKIV lOT 'ST ES UNEOL deitE, DAdS hER FETREFFONDO PATIENTUBERDIE LIMITATIONEN Boo OO[IACTUGCFAHGKIEIT DERON DON VOPRAIOHTTUUND UR DITIMPLANTATFSAIDNVdERWCNGETEN GTD FATERIALIEN hUlD BOO dIC. DARIUS ERGENENDONNOTWENBISKEll DE OBEN AUFGELISTETEN ERKRANKUNGEN OZ. STORUNGENSO
WETGITOHED EMOGLICH 2 RED vi UZIREN ODERECMINIEEND, O AUFGEKLART WIND.
Dan coo~d _aic and v. Mnnoer liceMaaece Jde P.ali cren mc amenBakiehie slice -atiegendon hEnal.eandecbans Snnrto
NI .1 dIhdecs ralan ric r hotiget hre Nieietian deitlete, Andci canne Inaned~haetepea tii I Rdik 1 deecIIaI e I and anII di. Pios il ineneccsclrn Kdininee etheno, caboi e- nayVeNat Den ,It~Iddeos eIder enlmioenncaia Foremen, d Icier
Librruie krpelicIe Ahiiat edenTADma en de- GeleInheret kareen za baIatine, neenane
Jde HTOOe..ate ecfinand ear
v P-oc.i...acIdenaci Fnhc andVe-sIri ance. k~, , Abrieb IderT itnpiar ,nOIIIe DieOladtoel LebII nencareIe- pIdloietineoen -
Htimlalale, III .E t AUCHS1N FORMATID Prtoeratie hOR DRERATFURCOLLTO V00hO DEOPERATION MIT DE. PATIENTON ALLO BESONDEASAUrER DE dICe AGE DON CATINETEN AUSWIRKONDON PHYSiNALISDHEN UND PSYOHISGHEN LIMStTATIDONN SOWMF AIDOAIPEFTE DOROPERATIO)N UINDDESPROSTDUETS BOPECIRlEU.E W~h-on den mdespacire saIn ace aIl- di, L ifntali are oIen 1Delckrlneckior,, ed -1dIeIsia daroanenpeircden Cameoi I neicscnmcn..de.,IIFencerclad danacttate-enlsamnemaher daNItieI , . dlirdisanedesoeeeoneeendr I.Di I Zedrcfder,0peroA beceneeneimCm-ickoa diednblino Nden 1dItc dieAinict, anddanGih dc aise 01. r eIene eateceo ec woder1 Di pn.o.e. iaaead prtintJinhcOa i ipotnodosnCiSoraakmcnne nice ads dot ceicandinovl- -aeohean te boegga_ n demcre enEnrkieeie iairtfoe onmen one.DeCorlcrolerCtZeteesreenode mono~ie N richmi dicrpeI tjo heelmlEnanjeceehni in--etiCcera c . d-rsbce.Fntmeeh Cannon. Im[ard or, ZenI hn slotsd d ida tanip ceieneFliicoe Onaimndnanam eitcee .'.-neoIIe ibiene t rnoctne Idaner Iroc. Abd In r 0Ptr Dee Ktinseet. iaeilcnedne O id neeneiedni aomnneema ,dose emTilamei dne Cnisniianhaec a Goaice egeencr O eNtilrcc acnlit-orali h,,ro...ik.andVt sine can.henceendtiieiieo T
am Gc.AedreiejIs do&rrocaIce Inanq II imn F-IIIII innaae eoeineoe Gnt mire-111 tedecheNIocc Fii,,mineoeer aeitoOr -i aedldiren ed,010 h. dcircGra ClIne K rlpforo am rd. . IkUI1IIII dienrdnGeain.simnei~icagei erilidere f oin c , . SalneI Sadro. d ACdL-hnne nete nichel. een cbnnomo me-den bin die Kemsnelon ncrk.1 ,Impolle rah ceden.CeramiCFomarhale aderjnin h andoreI nRiaencrsncnedndoescnicoiceccre drcl0c ieDeeaectceId ... KeooDIgan Id,,do KmsEnic an1ninhtcmhrbr , hir jedoh d ercci Ano.oc-,ndc tdihe.I Onede Iplnaiorheee lleeNi Feaneolo no1i,,toIIII Kec octAddee oanea norlenc Ilt., Knchenpieer oIoe. e. 0 rmdlnririna . een IEaeondutincclmee Iden I AonccIh-e ,eddoneI Feaca-KonIn CeIcer den si b-ne Sia-n en a dein ou einreli Dim care -die cne des Feeote a.Idek~ OoeneiaiMortbonIci oI--.aIIheeF RNdc an i, IehnpO diFtn-c norCeitrtdecIn her 0 IciShI-etee Til nicroneaardoentKem kOshaelnPthcdc jctmTacn cideracideene Incoec Mateiainein KanaCOichiei eccddianer dorindoridpana nneeb- nen mnde. rdrenn,,ecczaEcnoncaneerabo oo hotebneecreerate d.ie~I cciihibcaesoIogedd I.,n terage donrader boithie IrdeceD. EhIAR don OencnU DiNtttdI"on einn Pnteccalcnicpenantca 1s doea co ccdStcdctaeboe.micedea d... esslieOhc etii.ce ceIII idi nedeIIIetcedo. Zc-1NdjulIAcIeieh MmreeCnosi niarord, eat .Idiimlonotaion oasiin. DIn erc"hem 21Acidoid,Paice eden11 PAsirteridrn cec.irticlae icr-ntAniecbeRI . ,ke PIeclNnbdinacrn meC Udon.. in hine na acEmiedeo ,,Frkislh- CI des~r I 0 ltpaets sIt na Ca.Ute." do cnnieAreccoelian pIaienter Fead ht
deOlnce -Odroc pcoIme-medjoteFok- I or1 rad adorLecindcirpatnntrlo ae i edc 8 dnAteriric
Aneloctemetnpeeen Id civTU1 CaniniceceII oar Ca cc lectiiti .ac. hicioate Ion. Delc Cctc IOIhkeen. t. I Vondeer maneenchlc Ieice dieKeoecricc I -I :bnnaeie nt dK hrnm- o on it3eet1 hoe onsndnh rcin
~,l
GP Sterie
Sterile Gas Plasmae Sterito Gas-Plasma
- .te, A -..
MFG:ISieIz Manufactured By:

Mat HUrstelle
O~~Ebrii'4
Jt EiB pa :
Susi, z e Gre GrUBe, rail', Tam ta Il' i, tmao d'mes'o DOLimension Tamartho, taman~ho mtyr'oq. pETC~o Maat, mast St." orrls storrels Starlet, slorlek Koko. koke
Sterl,
pLasmagassos
Pradotto da: E bricado par:...

FAbricadoar
Gas ENtDOri Plasma, EsterI PlasmaN de GN~s
PE AUOOTRIPEHLHV
Steno"'Rgaslasma SI. e NN Njslsna~ Ste.i Igaspam Kaaeolasall
iop Acp'ouA
CLRIaT?), flpo CIEUDR
FubU-kLOnt Frotistillt at: Til .rkam: terilisoito VN ltsisLNja
O.D. /1I.0.
Diameter / Inner Diameter COutEr Autterar Durchtmeeser / Innare Ducmssr DamL6re externe / imetRe intern ncm Dametro esterno / DimeUOt~ro DidrnEtr Exterior / D Interior ~detro DIArnero. Extern/ Dimetro nteMro EiO.rcptlrt 51lLECTpng P EOt.rcptKt 5RIFETPOP Buitendi~ameter G binnendiMamter UdVednig dIameter / indvendig diMamter Yttre dirameter InEOdiameKter Ulkottalk~aisNija/ sitttlkalija
C
Coalt ChOMeC Kbalt Chr,,m Cobalt ChRGOme Cromo COEallo Cromo Cobalto Cromo Cobalto, Xpoipto KOIOAMtO KoAIlt Chroom Kobal KPRom Kobolt Kron .oi K. bOltIF O
T
Titaniumr Titan Titans Titanic Titanio Tittno Trrdvio titaniLUm TitaniumRTitaniLUm TiAanIM
PE
Potyodthylne P.1,Ieth~tte, PoyIhyathtlee Polietil~ee
P O letien P. iet I.e.

flOxaUoitiknO,
P.lyethtleen P.lyelyeNO Polyethylene Potyceeni
MADE IN
MADEIN IN HERGESTELLT EN EABRIDUE IN PRODOOTTO EN HECHO EM FABRICADO YTHN KATAIKEYASIHEKE IN CEFABR IKeram FREMSTILLET I TILLVERKAT VALMISTIJSMAA
~CERAMIC
Ce~ramc K... IN COUraiIBM CeamicLa Cerannic CiRtasica KspaU~oix6e K,,eramsch IN er.arlk Kerasanine
ALUMINA COMPOSITE
Com~posite Alumina AlueiniamoAid'Verbnd Osmpoit aluttame CsMpssts El allurmin d CoMpuEtot ealtenirt CoaripbIN dealumrina
EH
ETS anisa
Aiumendormposiell Alumitnakomposit Alearmipmkon-poeil A[Rrmiiaiok~diyhidiete
ORDER SFA PHYSICIAN BYORSN THE ITDSALE THIS LAW RSSESTRICS DEVICE FEDERAL (UISA) CAUTION: GINESSR/TEDGCE(AUS N PRODUKT ut M it SEMEiNVERSrANDNiS SOM BESTiMr ASSOFEEPS DIPIIS-REINDESBCHORSE VORSICRTSMASSNAHMF: NCREDEN KANN. N. UN I UTILIE STOS PRESCtTCUE PAR MEDLCO ETRE t DES ALALOIFEDERALE E AtISUNIS.CEDIBBLESItNEPEST ATFOZNTION :CONFORMENMENT NE USUOTRD St ESSLUSIVAMENTEPAMtE PRESIDIO VEND iAtDi QUIESTO lM IVIGENtE NELIPASA)L iA Lik FEEDERALE LA SMTENZIONE: LEGISLAZICONE DiSN MIEULO MEBICE. PRESCERtPFOEN 0 IDO SEH iriO SOLO PREDE VEND POt UNMEIIIGO RALD MPLNEOlinESrEDISPOS SE LAIPYFEDERAL FEE.UT. ATENCION: HME SEIrEEDPOSJIDDVS COSOS EOt RECItASEEICA. AVENRA ICLJAD IM~A L A ArENQAO: LEIFEDERAL ENroAH. O E. E NAFINIrHI tOt AREIAMOS01 trH ARCSAMKE TRD RS RMiAEi HSOUAtDH DODKERS AKHNomoeEDIATrON E HOMEOSSONA SPIODRH: SLRKOCHr. ARTrS WEROEN, it DORE OrOPtAOORSCHRVANEEN HLLIEEN MAOSIT PRODUCr SEE IIN DPOELE1 SEVFRFNI STATEN Ar LEDE PA 51EL.LER ORDINEDtNG [EN SLUN I LOV TILAMERHIKANSEMASET EPRODETEI SAILOES H 'OIHSiSTiOGENHOLD FAR UESSAPRODIIETER FENI SB~RVERUIAI SURDi UTAAARAYHSESTA tFTTAVAKSI ENrOIMESI tA N I AMASN IAISTENMYANS I AK/SRI (USA)I .AKIRAJOirSAA VAHOISIISISTVALTION HAN PAORDER ANNAN LACKERE AV AV/ SAL/AU ELLER FrFEESRALIUSA MNST LAO
~i
ir EnI s a -u t I.. a d-mhl; A t B.. e hccicoorcha~ltm niobunkercand Fheraemersaowme Beijstoocngseinsshrarccncungm die acm.sge~d~ardenicie cm, or I I11 11,1 l~ EE.,,rcJfoipasieehjdr, ,Ccjeco,o,coocIcohehdw,IdEcirlaeht-<I E .1 I,
an
in g auf ,
dwiem[,osi 0 ~ Gaewchtr beialacgnmc we ae,- (icacccch corroid~
e , h. ceir iremita iicIhi mehra ieLas erardeniL hoer,.soocaidom Rai m roher cKrc, hce'hi marhoe, 1 ~ wird em~oh~em Cat, aentencr i ache,,, deroulrjhcen pieasier~rcivenoi C~r'ii,,,,im ciurece'iiiicm~eo Ko,,ir odhrncee~scoinaaeooaubeoceiienLa d fktndmI olr'ercooeirwaccdo, Impiaccoce. besaordrar abe. rei mschish Lrhaituna der impcaoatotmxat~en
der Traclflicren cue der jed ijHlMWoe aoolh amcebecannt jet aind bemieoor Koenhreccntersueohuncoa Puimii~]o~olaifnaheii vial e, hoioiscarmcilrirern conl mu~do,
h,ehe,,con A,,rihen zoou vcerolekhxc,[meRcfdrcoag~.auhdhhmcrmerdeq rd~ hiekinetheBeoriedlur~ des Parenioe,,miiieicihooeiCienWeen
dohen Roe~btjeickortreiien deceaderoucien leetoeste~litwarden asimoe emspmel zu trahlenduirehiassiekemh Knorhonresermlich
oder cere
i'cc,lst or'ceealo',rm, ,oresIplaarcacs. aiod diescoderandorrccenendmasehhi 9 az ehe~arhena damiteicuitteitoce~den hann ob sieecat~arhseder
1 po~oecssiceidund aaeh ob der Patjentahcemessoe behandeitaciod
NEBENWIRKUNV KOMPIKAT.ONEN ENUND
ce,loloredo, *,ecr irm bei dec Hdjiclehrcciplikt heeihch~eco d die haui~eniichc Nbeacnwirh,,oeo acd Kompli aiioonecaiieamainear~eoeben h dooii am prO1h e rlielre -oepemrr . die rir:h of1 -f*udirer i W^hNUNLOCElIIID iRIdiCHT2M SNAHMEN ahoecelaenenc hiaktren heziohee 2. Iorzeicice apace Locherced dee procheicah cider Komapon ei. die IicI ,1 auc li icolo, WARN UGFN UND PSIC IR ISMAhSNAiiiIMN a Ieeebenenl- ie aioe :. hrmiidurcietraocc des lemarsehaftee. die rich oh a,,, die ,,eter WARNUCIGEN UNdhh~RbIC HTh MdhNAH NIECanheeebeaee Fahlocec bezieth. Ahricb h -o eorsdiole ad,, Ereiddcorsf, aktN ,Ir,, I-ri ,,khaer ker. die ,,ih , ant auf ome aei rl iNUNi N UN[a OiRSICHTSMA^SSNAHIOEN or oecabereh Cnkce~ren~iaeihace
irdhedabeI - $S ab, feirIIi
0. Ceriphhee Nerropathien. rice eabhianische Neroeoaehddiccundhanoacyraundoar, ehiurc~iroehm Trcauma~c *f~~ 7 Cnowcbaahcmonen, Osloleocyrd/adc,o r Locklrruhe des Imepilarate OdccirL,odan cMecaickorrosonch y aiirlarhe,se Reacjionen
ode, do, Aonosommicc, Abrioepaoccin
yen, odorlaceo Zeementleiiehehn
Inroperatic
2 peloracioo.Ciacar ode, roccct ci Errrec~~hciftes, d dmeo cegebeneoalos inteornee eiee icdixton elerderiic hmacehen
2. Triohoaloecchaktr
d. dohodicrc do,Elliealelo cic zum Beipiel derA

a. ompeoraee peImaneoolnIeerconsohadd adr, .i
A- ibiac,
,ii
inA oraio.I
sodora ,cerezeiterail N eauchds
doeN- lem oralN , Ncbtu-aton e
ii Sebiccacimonode, Disiokociandes l-dheeinks aou9rand dorAcswah leo,,Cardoebias Ka,,lcmcgucctm iepiacctaos. i, Carsmtmaoierunc oed oar Kampeoeo ,,cen dad/ode,do Shla,fhilt, dor, uckoloa urnd era f c.iod..ewecs.. mbrseo. 7. horid....r. ode, h ,ieroarcun de ,blaeon ita t Friuhopasteoperatico Phase I Karod,ooaskhalri hEreranlkccoo oasehiiheliHchleoncnhroabose, Lanenoembhiie Mhohard anad inlcihi
2. H.a.a.are und/do. rer.oI ee
Waadaoiiiu.
3 Pizeuihohue adcoder Aleitcaso-

A. hSdaaflj, cole hiciaoatio.
Spdtopostoporatiot Phase - Tirrchanborabri C cauceund hbermacicor Mau~akria,,capan
[ang eaaiahhtsbeasiaec unbabsoahtihiccer iin~raeperahioor ade, hocoehrwachu des Troohamloar 2. emshihmmc~run do, Bearhwerdea ih doe iesiilaoralen bore koocdiroalae,~e Kncc are $prun~eoencen aafrn ie ldoiinhda nediskaroepahndo dermediciea Voearlcag~on es Coma,, cad Murkeidohioienoce. d I.Fema- ode, AoelahaiamIrahlar ascfracad vi, Troaum a o, iordeir . a n B celaelrc hscedcr he' ccrie,
areairhode, Ioceheo ewehos aecherer Oseeposo, Knochcrdclekteo coa -eracscecaneneo, Cipdramen, ilr.oporatm.. Aab
vena.rlaenon i -lo r aoneKoaehenreaarptian 4. Kaecrelsarpioe dir zar SehILeh.arun -r .do, icaPiancad soIhiiile a,,,lLoolae-rrg dos Irplenec boilracer kane.
Ca,,aermackijrrhonekalkano dorknocheunaadie zuaairer, Eiseohnrhace
dor[aeienkboweciiehkeit aad doe Beawehaacaboreicehe cdhorn roe,. c
K. Iraumatseoho Arthroco doe mp~acirer Onio air Coicedorntraoporatioen Pcdmtmnioerun Eclromill wodhroenidoeOperatica. aloo do, 7. cabiocalioc odor Dmeiokcaiao.
Die Inoidooc ard do, Schwerecradvan Komplikctiaren beie, Ha-loratz id ir dor ega cro, beI Crocresena h R W eeielopararione,
bei ala PrmmeocrtoroonZr den hoduicc ea rbiemrro
boi do, Woehseleircraion achier $hawieriohcitce aol do, Inoiaiocspiooimec.ng Eatlforian 000 ekcopera Kneehen acd alter, Kaolhonromonh moni . run nid Cixationcic Kam can eaten area r-ei
E msecer
Kneestdzm alloemeicor sind IanWhoseioperalioeen cine idagere [aporalmooodaer, ilavrnirat, lclfelionsrisiko. Luncerormbolice ad
B Wandihbmaramm, h acami erwailc..I
er .u WIEOELIEPERT Der Femrecialaum, dcl Coecehkoph dan dootaboirre hraien Sell.Centeirin Hail- arid dir Hoemi.Hcdlltomprenecocn wardene ie STERILER Vorpooar or anzlsciorpacktcoliolort Alia Molall- aid Keamih-Kompaoaetonwardecnmte,[cleteahiunatodlmiojolLiHcW~eoKareponentec u o kennanrmitteis Gaos-Ciasmaaoe S hluchar slcriiisioriweden. wsiccaadoe, hchiid auf doe daiherodnpoehpaceku~accgebenreslnaehdem dime E kaorcekte Grdcc heclimmlism, dollon die Kamponesten cater Bearolcep oclemaicr anoptiscerhKauteien are do, herpaekacceoammenwordo,. Nuat fur c Meltalalomponontec: clean die acedeie Cerpcoekuoc bscrhddioc orrrheiocodor die Asepeis doe smienie Implelaltat riohl acwahrlosttisho daireelancat jedoChracehMeicare doe Chmroarennoch tar cdo uriapnhciichoi riesaclakzeopalcelismurea dee Gerat car Impan saiolecron 9mb der coipendenr Anmoisdreccabe~pa1tcardsteriiicie werdo,. AOSPULENOREINIOUNG Stcarte asaet aoe phypoiaooisaho Kaoheailolsunc c Zimmoenerperator ore, hinwcirch dos Impiatats oerdseodeen aa Impialantrl~ W a D wsenicalocs aMinaloc cinwoirhen. has pradukt safest crariekic.Dee irepilaltator der Stherilisat iaaniooinsizen STERILISATIO (oar tearMetallkomponnnten)
N Coicsie Sted lisacciceiaer Mtaelkohcopooehte chfic d wind. wordoc die loicorerdaParameter, mporle dhe fdr eia Cteriitats-Siorehejhlats
e cisie Nmoaa lStoeriiir Asurancre Loael BALi oar 10-' vaiidied warden: Methade Zykluc Temperaute Eitwirkangszoit Darept Cracakaum 1320C t0 Mi uele HINWEIS: Dir Eicraro dcc vermendeten atriiarionmenoo~ahreae ae caure~ciheedeestno ocorden hr jar I~riobci keriach. cloidasaulico m g Pcaedcoaramoler fdr die Sleriiiialicacecdle do, jowoijmcenEinrichcare and die Pcaduhr-700laddllskonfdguratiac ocn in do, cidociet Sleriliaahianseoelanorcnaciremchodacacebmidlore acd ahlampoeterorm Pereoral eaiidion cwoice,. doe Prazec ecasircri~e Zaarierlas4koit un um one Repcadcaiorbarlreirca ceoldcigoc. rice eilt-rcerilisaieoti hann.fall anmendibar.com~c doeRiehtnijejo do, joawomliooc Goesund heicscindolnchun asrchcotibhrwsr~den. VORSIOHT' ecomisohe Fomuckdpto.Prothsecor mit KoramikbeochichtacungoenudKornoponencen, aus UHMWPEherogesoelltwarden K die odor dietes onthaltet DURFECNIf~Ckith wieter oontne~lmt wanten. boes Kemp oetootn tight cereodat, 'race die ~tterle Verpackung besChadigterelchent.
rn
PROTHESE HANCHE DE SELF-CNTERING
T M
~~~~~~~MODE D'EMPLOI
ATTENTION:a fe tdddrale arm~dtalna (USA) auterise etc seals medeclota Ia vents oa Ia prescription de ca mat ~*rli. roi DOESCRITilOP PRODUIT 01DU PRIOTHESE TOTALE HMNCHE DE to prothdee olale de halaehe eanmposed dneo htig fdmralie ec mectal duno Idle fdmocaialermdulaire en mtlo neaiu td oompcsantsarcerabualirm deac poerjos en poiyethyiene Cd eI pado moruaimrci ritra coedaiuHMWPE) door reoereorement md aiiiqro ['Metai bcar'), ehrramique roduiG toac UHMWPE. ercbriide irdia idaoliemont, eat doacode cc rteaplaroemnt do ia surface oraftieualretarelio do la mc. La cratbwas iarcehe do So~elfr~terinc eelart ace opac~alt hdeispheriquae raneistent en ucc rupale en metai, aninsed on LIIHMWPE 01an donne J eretenionon piacticae. qui dojoer dtre atmliede crier Ia cigefdmoralo DoPuyet lca cocomhtlliqae mrodulise, dant le diamotre rantreapndracaudiemolne interne Fiaisc en eaihdt llrde de ir prothrdee eilf-Centerintgr purc roimplocroIa Idle to ejol fearmur dcc$ dt h rai I anhrahcaetlj pahiojie dejla Ocorhoe pratche~e do coerhe Sellf Centringeatealemoenact utilado commo semeasent dans ieaarthcaploesiec La ttlsdo haoehe Ioccacroqella scremdedare asadaceo suppaci or UHMWpr. do dioadtro jinrdijur caorrespndant or diam~rre eaxtdrmoa et d do iarrerl~e mdrallric uetlji$jed Oeratlie Or UHMWPE pocedde Sc oernr Iacliani st accalorlelo cre ie raf ec solir$ earnieo~d afat eiji dilate e ecadid i lco ~lSepar- dcesseaIc hee roldiaco do la tlte Idmreale maca lair. eams neprendsa tarionaiciriin1e.Lc capalo or modtal oetncailleirleieote on UHMWPE. neo oduetijar dcesai ajdr 6aideeecore doe erpalos dieseai cet llqaiiscol doe ratoliecdo dimension, ilecfiqaoear remOcamaanta PROTHESE PARTIE LE OE HANCH
L Crc proohdese parlioeie haocehco.ompceuntacoce hdfareaie0 mtara or dunoe Idle. eet darede~l raopiareo lahole ct ccCar do fdemurcore
de d 0 do Polbahrpiastie cartiejic. UTILISATION pREVUEET INDICATIONS PROTHESETOTALEOFHAtICHS Lartiroplascie loacai do haraheoa pear hal doapporlec ad patient roe pica grande mabijta et do dieminaon ace da~eriocrcoremeiaraot I arherlarior do la hriensdhereedmapoo, laeIorqnalrai precoe ca l reocercffixetminenetd eel, rare permcetrleI-impiooteUoncdeS oc rompeasa Lcle ereiplaaomentrtoraidc la Iarheosheljn dicadedaaa leosarcssioaoole ro~uie IArhiralaticodoncexrnleceantoloacureus etouhcanOdleaphe al~adiuto dare anthrase. daco arcrto coatumatinuee une peaiprtlnt$rrhucatoalcde t d cc dree dyapaicei acegdritole d1o haeh 2. NdCreeose aoalajredec~aro ad dufma,. 3. CFractrelnaomaliqer do ja t0ce ad dci rot da l~mar 4. Erhoc d'arao precedeartc ehlcurie do la harche: reocentitaltar do I'arljcciactc, iationha intenrne arliareose, hdeiarthrrpiel~sie anthrapiastie
par ramcplacoemen des acrfacosarliaclajire 0ureinplacerment total do ia racher
5. Cerlalca s aSc'akylose. C Cempusrets aceedte~nto poreut poi'coeatte Loc campesanta doelap~otedo tolabd ddecodo.herico fametaic a cevterleoat,orodax Ccrrcabotaaeaaiooleicydiecnecace realaocr~ecrn ,rdraiihqa jMetal-backsa.evr endea pcar Acre atliizes'arc rimmoc.a fijxaticdool tantoe~rde par Paocdtinlntcriatl dans j ee ce~ement l paodeu, l ruodiereatormv temetareaxrservant IAaoometolerfixationrodeila pnohdoe arimeatle~u Campesetntccimatctde
Lostemposantsdedola proredne ctaloed c derchohhe fdocaieolaleapaiocicot lodanono Otiqaetes stliliae riunccemoe ear rmer "A acer riaelt.oart,
prdaepasipu tereseoidn adaleme oct e Composants A ceveroeretc p5omatx Impachor I scalier not C toJ ~ Labilefemaraiedeoa reomont non poreux Itiqueerd "oar trapactbin 0u sereieomoatanicuement" pidoropoal dtre ear jmplantceetpreps-tit ec non
TM
3K
do GIe I,oen.- ootdl ten nIl nap do aceoie on
dlo
bj de had ne I.eohe ,
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S.ovleererrd CEttencecoeeqoieldr ccerefq-et en-, I lIqodc aereanetIi kec cd natat ooetpatik nIod Cenildk hatd Ice. paelinne t ctarnedb Ienln nf-n emcee -d at enctatt idc, ceadi~delded11 eqd Cricdcat kAlanieh Itc atieste, do, Irantitcntkei sand Cretn .eaceIi .,ti ...... .. ondcce...tt. t ,n ponontet..,o, ar den dlAncdes IIoenen-n md, n dHMWE ejiade, Idenhar en irdendig diamete, den, oton o e c den ade-nniarI-.,A dde -setdte,1 diaee mea-can At11-eosennee kempie Iecnttiteditore onde tdiardedne., iddien 2.~TIIbern oetrre"IieoqdenC;,Ancell inidjc idoldnentuele. iren tid atet. knotnareeee,IE Cat.1eanmIaatik dcc, -emptekefl-leecttir Kamptot el. eaectaecii 1iec~~d~ Can anenaciein cetne petleete. els iAlc vundenen c indkae.iesn non f. h Oiek-ettlecati a. Aepeejdr Itonbun.11.,1det med pat iertee aider,eq erodedJandorCa states1 econneede kiae tI aeieltet ec hotteciedsaiacticq (cc RAtctItt ADAE..SLEES FO.R VIE E.tG~tHEDSt5EGLERI Dettellf~l. teate l -d dom Ed. patientIn Oadrkttc eknb . Iled enieice. ace1 heem dot at l Car KOW.lRtDtKATIONER
Fe~iaedetIistatdeer krni,,l 1ditntine . eert-Ir k-,,epiorotie Oat, Oatleenttetne:
4Cd.Oaret OtterPeactaeoqd-m a1. lan Caiotneitcntapacie akeh-r paeeiak t1 Iilead aeaaa.

absemlr, .i Itetd-d acetasei meIll eeeedqeit pnttroit acoabali .iarteAtdoalA dle cit tetrd Jctae, Ideudetlke,aetdine
at den raanIqocoaecnsmnpsce aidiII ... t aetad tar 7. Kercereneato kanerairndiecr-oi eaoo u rdee nap erd MWPE-oap ellfdilller l.PFct to~Ied f.nlebtbtindtia a8oaoeRxPceede ideIqeakl or diabetsikee bisec tassat cdam td-en IArtIndikaie.,Laqe, Aet iidettid otteaia rird-n em,den ArtIlndl.ieatdtreeCteeatiqpccall dldl~l~~, I d opt mcd at-ni diabete pAarad at aqet tIi tanI. knenpiikatarr steam intetio.laaADVARSLER Ed FOR5IGItOHEDSRECLER
ADVARSEL,
sine, at et-riumcbitinaiRodeZtreenta-ksgtorpsduooror on forhotdscisttttomacad, paRVIteto, VA n n6 do Voote ommo me c VtHMWV.PE octbuu-ep, lactate,, don sainted tndo parnkItetubsqint Do bid.e do einmisk prkttntokoera~nger.., c, E*VHsttteprcVr.e.e.nIe.ccco,mhidrtg" got Stcoe. in,pItaco thesbkadiet ud, tendot how udklete mik-oskops Sico ... erit, sam hoe sIr sIt snos. * ,Ascend otnd proropr.cosI nIt pr-sesorsatt Provepre.oce bar takesainte toed kmon Vod,or borteatnel .tp1 msc imtasetg.Pevprsoe ...I hsssanmokoegrVtonsVIetse doIis .s . VAed kmnqpcnncr do, sktisntnee *Fmurnoteerrtt a gd eclt Cr taia todat -ki-hle prstottos atdotcmteso. V. .ADVARSEL: Falterde titeede, enniti oile.lldr
AiAncmotttaderde bldestr~deatedsc ketmieae t ill 2. Fpak rbede.
3.AtMlo atrtsdett..Adoa
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ketisnte dfti.ek., diRcacesI melit, etrI dteap, 3.Crs 00cr qonenIle

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7. Medtad o.AttrEnpani. der ear, ndoconodc, tIlaeat C. Vm'oaeckiarttririrpattomIer ote nlte,.tfldhid
kne-alotc
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ANAK RURUPEN AFOR. ATHOFTEERSTANING ER BEtDEOTE F MEDIC INKE AEEI5JATVl G ESLUTA AT ANDVENDE V. PROTESEFI PA PATIENTER. E HARNOGLEAROVFN~sTAENDE D TILSTANDE ELEERER UNGO0 AKTIV,EA ERDUt tVOTtGT, TPATtENTEN A INFORMERES OM DE BEClAeAiN0RSBOGRdESteGR tOM DEANVlENRTE MATERIALEN HAP,SAMEOM FIKSERINO00 BEHCOVET FORVAFSENTLIOT AT REDUCERE ELLERELIMINEAENOttEN At, OENCTAENDtE TtLOANE. Faietntonc k Iitaeiko aettardtiIF oI ilitsetbhad Iir eat1 etententeree tedl c-dee hotnrttee dIl.1 n. .i . I.ll.d eIddIcqenediden tatEtytrtc, dA. ar. . -oiee en Itad It at foi sIr t er edeerd .. Cartotinke trebrdois estero -eratian e tartar
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INFORMATtOEN.D..RENDEANVENDEL.E . KtRtJREGEJ SeAL DROFrE ALLE FYSISKE 00 MENSTLEtEGR.ONSNtNOER ICOI-IOLD TtL PATtENTEN SAMT ALECASPCETER VED OPERATtOPIEN PROTESEN 00 MED PATIENTEN POROPEMTiNE Dere cmatebt Irktder b.1eqrccicc to iditeCencetcco eted -oEetatrines-in .rodotd Rh.-e at col at tMte kiete,e iectnckide ft., e ipceirnn Cersor,c beasn-eot ailolitet a es cad vastt. Preeperanie par~imair Id kirutaick tc1kn eta imr~itccisa at Visftnatetsariackenenntr.c saa cder CItatk tearc, Edon ,e cesoemIndtitvn at scrc hatepste.. Kitrdln seat trac istdaherd ktIekalkb cii Ctertc steci Ike ,ientatRinactcettie, tardeenaq- bIRoNeat-e m l. kocidrCa md, Creneotielthd- sentderirdacns sor klnik rnfatr.E M-do Ketsk c-rdeceg, on saOre p-racesreceoId, dneeenscatpact . kitqik irldkenteAtaa,,, -a dcctIidsateotn jeti.O B1 nor eq cle, ra kiCitraok eerie Car clot-c fra DE.to ctrEt-oenedresdII -d ld eb~ i.I dettaeiaMeaeebsentepraaeteapidraeepoecaignt.cn1 paaedeetorrenso ierptao 1.l-f,. B.cskt,ttdo eim~d.R.irAorkc btieoA tg rttCepettn ph, rCtrttipatcng ecnaateckec lo nr apnnt itancceode. Cco e betot astphrest br 'en cch~d toniee. enen c at t kadn akoensitri, iocCr n skdeCa d itid.liaictctecon didt entatrekiok-e anol lorcN-ere.M.e aren Foe. ,, ... emnnaesc totrec te trdn, t.IMareqiecpbn arde ecot Dtreeei.VeeosFreAmediegem.r Ieeta ,cacbeio at, temccattec k-enteLirar at dea Mlercidet Cete .C thanen Deko Can odeteceonanceeonelie tceekniaeermetet tenukoae q tmoket Et iee eebeetnedne-dci cootpaten bT t te
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koneIikakE.-tcmtac ketomet. aneeimd kdiasactIeradiesedn d-er attloe Ien.l IRhr necasittio e ecis1t ttba emnsrct-cdncieecpaeasenttdtedt totsdi Otncnd IVddorcdae seen , oetoeren 1 . n ,ttooipasatt locetid.-emc- atds emnsaf ,doter p acneiara, teae btcttne Pd.den prt~and-ale cstetoeaeeteacde kc tar nititIa-atce iee. ' 1 FenocIovcOl teacharnere nnodr i kescpcncn pI., kemolo Catnenctatri kendot ,,P
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LSIbfhIWLU''"""" tddeo.-ssefte'stPest'slteemettm"xsttsLantsasost odc bcIe, P' d'ane. bPaIe dI!I Itt' Psatec'iviejsln'O
,ts Ut..~~ss~t~sdl p.te.. desnetIdpi- ddtltdlntdc .1I l,, [acuel suivee disetivo- ha'bitvo ll' Is Phase1.pstPodtsl-ir's.-I'I, L loP.setsetao d'ctio sems ' htospsel c od
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desnuIs
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v'll cine1doe ,nosetieais
par P.t, xemteden asses dottcvepan-Po, one ndppit eee
ET IFCETSINDPESIRABC.CSCOMPLICATIONS asaeets, mesien1 dIonsli Istbtia AVER'IS~pMENTS STPRECAU'PlONS. -O Ia IDedemssdo pvthee.snaeo cntsI- dat
haodi tiqe assni Plb-ast' as tctan one'ssl nx 'shtius, ls pre.Pay vs Latifdos pstpstt Utanstelle IAUTIONS S 55/CI P xvi ixlpsstd, hVRI~I EMENTPST PRECAUTIONS. dt atbis tP.llan stind acen hoe. ILLn do 3 - 1Pata taill cE rio[a tine xoetal. dens,hatesniqa' ORIPSSMSN'SS CT Alo aahlPsesec'stss l... rsP..ss Pv polpetpl.ve seevest tdbau 4. sd5 vsIIIsat,'
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slsoc pIep'Ilel all dos
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d'ntillcx henPamhssosd do as encases heesy ssIllt i SAL)Lx Id' '
tup'sut Tt--dde
tdid. peas
Illpsonn psasdant Is retatie et l'c~iet p's de s velce pourchance ailOP.oII tlisus is et cot h-iantiot Ptadv-tPiatse pats beei-, anI's tslisePie fles pea Ott' psiI'ahe e sa altPCcirI poxpedanto dlasiil of so nPsvdldacPiiO SIN .ieIssp bt, prac~d.s, o stPi ...... t1tes fletscn' At-TINTION he's. PA C'''s'''shshh NE DOIVEINT ildtsee'q, N's pasehl' p'osAes lee-Ndd
SItotehaleg dseitdIqu .t'..elstee .st6rtl comet'sabes
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F'sde's Ic io..t's AIItENSIONE:IdhL'sahstatitsee PRODO0tO
DESCRIZIONE ECL PROTEStTOTALE DASOCA
PER LUSO ~~~~~ISTRUZIONI '..IiUS

rA haecetlt di oeeopreeldic ..EontaInasle. lmt' .... Itadi
vppcseccrPepl'sttttt EL lt metaihe, IIInIestd inlP.pihi lose ad sitiAitt pes me1ecehatIUOtWPIQ a in :-amc meta l-cap Icetile ,ePlld. PROTEStD'ANCA .ELF-CENTERIN. '
cc' motaltIc JA
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PROTEIt PAZiAllE DANCA post `ncuenom asPx stlon Luprtei IpEtrPia a' IND.ICAZON PER L'UE.
PROTE-t TOTAO P'AN.A
ldihata sci pantdi 3.Iett suaics spate doll set-
tet' aPo di ceseitaiP Ist osatmrt. s'tedi-tipsnl III pmps ..
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I It i P.eitisenaie di p:e9tens Phinatais pmdtes.Icd-ca ascItiast S. tu-ists tots Id-i met 'seeneenI Cotepecet nLsoc'tsslottee~tl-cp 1.P, I I Ias's Pe'scc'sa",P,.h.ttt_
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3's IN DI ATTEN.IONE: PER LA 'sISSAZIONE UN. PeOTESI RIVESTITA CERANIICANON UCAPE CEMENTO. EdSE.. i Test's t'te''st tredtta's'snts'P-s'eli .coA~bPtonl t scsita -tleuto ass 'st-u tledsnl dP t.IlL'lpOb.O dPe' OseetO .. " m LI 5est fill etal in -etahlc . iI tonai-ca Cepe dEe eset
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M . P...Ikh.0 kAI KE cce-oEcNadEcorNonalePcnenccn. D. dmiksetan O leresslakfncpntose I tera for te :. cash inae sereen.I. -diin l f-1, - kd,. I ihd . . f V1IWARNIN-1 -lbbNEC BENCiMENT Ft -AND , iXERINl -h N KERAM.1iKSlGdi E IdCOTES Medalice I Id lsae s saneekgpnne kerare11h,ajnre olar onlela nln n h Sn,nd-nPAnoe P d W CneOb~eeoese-hemeret r, I en eos.Cotbas e otnttsmdonvoodeP. lasoeslateo en~hI krare-nC aln -elllaill LIdM, id, ed alc rea Ielllakel seaIarsd retl-ki,U lhWO-t Oeliensinre diamt sk9aaaa o cedneosC o nooaanrheklnse e eads
onacitnnDpp dlo so dsro et femolidIoe E: ATTENSION stli d.l caIno delii sILI Icisa noee.isuade shn iimnio L 0"iI PAR"i fII~
I PROTES PAC SrC."" lndtI.... ..... CerteinloeonnnIlotioolaInd IonnII otolood Idn'i 00, dodjlaoetted'n, I. ,,,atadid
La dimeniatie de canto d'lt
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. ALLA CHIRURGIA NONCI DOV ILLUSTRARE 01 STESSODTLnE L~ECALLIATIEEiLCHIE 1A
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I ANVtERTENIOASRRECALOCINES3. ......Tutdo aiadlssoofrsa. oploioo Idqat o (sotur del coprrl 4. 04

PROI;AUG0100
tec.duteI.tttrsno olrda
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desalados 0,1 AOVERTENCIAS rcelrot
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do
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Pscslnl Ipaoadprial sossisistrap eotAquesdos s UHMWRE A1do o --. opeoo
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INSTRUQOES DEUTILIZAQ;AO
CDIJIADO:A Lci Fodoro (E.U.A.)Hiilaaeot.do doIN lpreitin A Itt OESCRI9AO DO DISPOSITIVO
PR6YESE TOTALDA ANCA
da-arc do S Iloree Totaldn Asco compostapol Csd temoro~ Urn di.. on pEr ordo do at, medic .a Po.ol oub,. tooraL pol dala 00Lr a ocrls oo
-aurl. doorticalapf do~ .sobliait ssopntisi ar.ticola~ JIHMWR rotorldas cor LtIM, sod- lacdridioodos lodisdool-Ist. ,0dosl so-s 0. PR6TESE DA MICA SELF-CENT'tINGrO
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co Acnood urns lot cosa desiaroa Ido irsoro do UHMWPLl . -15csid corn urno oroa A .odalar11fdopsIs dun ooos do cabi.11Oplertoornl or o.cl Nosro leop00 elr so .ecd.
UTILIZACAO A DUE SEDESTINAOINOICAQO..

PR6TESETOTAL DA ANCA
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bIirItoiracIo dlde e pi db cargo n o doticoARa doDrea. (Coratlar , ooado ADVERT~NCIASE PRECAU961ES. EoRes inciaem
DC. .RA-tNDI CA96ES

As otdicicre, serolr osttioe
-
cotte eDi...coesprsatitio -Il tora soL paciiOs00

tocarc-i- ioaoi , L-so 111 .. ,d bA . I 11 fLd .1dd lb 'ro oeocioooO''oreoiteropoanaoao rodfcdoi acio otonor bcod 0 ootn rceites ttrio o0.-b .-. I N.d O' .bR . 9.MorraiooedoAl.~ coa so d tbil emofar. rassos 0 irroo 00pdor -000 0000d i...0 oobdetd dsopose A m 00000-ssr d'dodigo....tr E On rcad o ,rtt 0 ie 10oasni ooa ooud asspottaipo
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ELVRECA PRECAU96ES
CUIDAMO'
* scbf s omoi do z si .tuni .nnoa urnmtr.lns do usnu on . .do hIndri. clinic hinoitdoA.. .mer .5tse domorostrom-I. quo,qoasro uilizadns .om betd.u. ctauan UHMWPE.As usbopos do aio.lootbiliasda su triopodz urn qtaosidsdo retioma oo do pa.Rulodos, I .qusAlidodo toal doptRlcoldos ptnaoo djfddttoirosds. do mlat ode Irey do nobtiesno au do sisomdo impAnts diforonto ..ute doo-is nor utiizdos fo.EIR..
* sunmnnne
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* Nor -"-ntInodilqudIplotoro do mo~de .. 1t AIgnet *A qtolidodndontttdAnostsmrsldossostislb I pssasousr Ooadproiod.hasttfddts-sleCe...ds-u~tt~sn IAIIl CUIDAD.r Asonits 0IObei~dodes ousrs 'odnoidool00 simoitata-tl. oaom5 irproacrgieotaoobtootmdodoarocttdo
pes soceosbo do donoto
4Njoj elosda do Addiv1ddsd d-orto

l. do 0.Poboldoddo coada.,
6,Alcolim 00.abosodo dtogoa
CAUIDADO: seguietes As I pots ladioldool00 sirnltonomotlt., d050cm oaacordoRanotait.Aafp ..... ssoostAiootob. bNN Dd.1.llI .d dos itt.iso Aldo prdtosodo 1.6-M M
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CUAN.DO C otURGiAo DONCLUIR CUE A SUBSSiTi qAC DAANCAE A MELLORoPQAO MtDICA DISPONIVEL DD0CIMRUTIIAAR P10T FoO~agE SUM DOENTEDUESOFREMECUALDUER UMA CAR CCNDI9005 AGIMANEW OCNACASDU DUE,E SiMPLESMENOTE JOOEOO I bAeD EINDiOPEEJAVELDUE 00.IAM DADAS 10 AC DOESOTE INSTRUQOES. . DORE AS LIMTA9000 MA PESASTENWiA DDOMATERIAlS UTiLIZAD.D ND DiSPOSiTiVDE RELATIOOAS A FirAyAo E SCOREA ROECESSiDADEPSLoLTAPE DEREDUZIRSUO0TAPJOIALMENTE R 009 ELIMINAOCQJAISCUDE .m CDNDIQCES D ACIMA MENCOICPAMAS. Do cuid-dos citogicss os-ooiobtio. od-Lorto 0000 set totodas 0000 d ,dooldoootsid-,soda tod.s o -Asdipotsooatoro., Alilodoo ds ... anbo -mrtis ga roit- no -tepoidadodo dooRteon odoro is ordons do ciraslA. p00d00todl Asrrcotopota
INFORM .AQOES D. UTILFA9AOA 0 CIPURDIA. DEVERAE.AMEAR TOCAS AS LIM.TOCOES F[SiCbo E EONTAIS CSPEGlI AS DODOENTE E DISCUTIRTOMOS05 AOPECOTS CIERUOO M PROTESECO.t C COENTEANTESDOiNTE.VNqAC CIROROICA. dioconAdo DA A A A dood, incIoIditootir,dopo 00 00ldd-. cotoqdrciosd~ do pobloso,-1~ arioaotooi.dodo do soguit so lastraqdo do iooa rosatRilattos0 pds-prlt oos-itensts quo topot daciodooos do d I .Asntt, I1 dd d1-.b~, ,.b . 09pi-omet pt-aotri asd tDcnie -Ird.sca porn impiarto1 -- to copnrtsO sbttapadoocdoouram0pasrd oIIIob n~MoAirgicaobdoI. 00-010 donrodmnodonuts rtssdoo.scnsoenodanica
-0 fcoslio 0. no1altRars do ll-oroeda totomadispoi. L. compootlo polo mo ibsdcor amtaosth '.A.oa f-mRN d.o monido gao o-. doloonirado n ardopror-i porn ocmsds V-Ito... idNlt-oradrIo lom.ho 0 do optoat1.sdo c050050000 doero0 tohorturos s d broocao00 gao as W.coma ots ctojm rato da sot impattdoo P.d utilizecagt tomato' 00 qoa-or otr AApset soN tior cido 00 Eaid Aor Mama saptoie doors Man00-oN t asvtoanst ado too norotiois mo , casooaioproced otoe Ats oimlnta- oap fmra d o-mco anciddmco o otsimoo dc stlip
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Draft labels
53;3~
41
APPENDIX C
(b) (4)
*DI'
(b) (4)
lI
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UI(,AI I( )\
LABEL - MAIN PRODUCT
REF 9998-03-944
T i 123456789
~, 2003-10
STERILE-R
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M T
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,Uaat 44 ESTANDAR DUOFIX Protesi acetabolar* ttlai
M:sura 44 STANDARD DIJOFtX Impanle accetaular totaI Tamafio 44 DUOFIX tolal para acetabulo *oImanmt Tamatho 44 STANDARD DLOFIX
44
DUOFtX
*Defuy
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rAENUK
LABEL - TRANSIT
REF
DePuy ASR M
TOTAL ACETABULAR IMPLANT
999S-03-944
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(b) (4)
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AUTHORISED:
f,
SOP No. 8-06 Issue 3
42
APPENDIX C (b) (4) (b) (4)
~ ~
Al..Bkl. SI'I;CI[:IC:\lION
LABEL- INNER
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REF
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TO TAL ACETABJLAR IMPLANT
S:Ze 44
STANDARD DUO
tIX
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* D~epuy
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!,
(b) (4)
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AUTHORISED:
331
43

(b) (4)
______
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LABEL SPECIFICATION LABEL SPECIFICATION
(b) (4)

REF *998-00-141
L~OT~7 ] 123458789
2003
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FLET200307 9908-00-141
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T
Unipolar Head
C rMAT7L
0085
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Unlpolacre kop Maat 41 Testa Urlpoh1fe Msijsra 41
CabeZa u4.polar
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41
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AUJ'tHORISFD: -
SOP No. 8-06 Isue 3
44
_____y
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(b) (4)
~~~~REVISIO
(b) (4)
LABEL-INNER
9998-00-141 RE5
rn 123456789 . 2003-07 sEs
DePuy ASR
Unipolar Head
TM
Size 41
I LE NLSS OPE'..E OR1DAVAGEE*R Tet. wnipo2aire Tadle 41 STERILE SAUP II OUVERT au ENDOMMAGE Unipolarer Kopf Grole 41 GEOEFFNET OOER RESCHAEDIGT NUR STERIL WENN NiGCHT
Unpolare kop Maat 41
STERIEL TENZIJ GEOPEND OF BESCHADIGO

tJ~l. u,"pla,'e M!muOa 41
STERILE SE NON APERTO 0 DANNEGGIATO

Cabxnza ,nlpola & TamSa 41
ESTERIL SALVO ASIERTO 0 OAIASADO

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ESTtRIL A NAO SER QUE ASERTO OU DANIFICADO
C FMAWT
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LABEL - DISTRIBUTION & PATIENT

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M
2 2003-07
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SIZE 41
nimolar Head
* DePuy.
(b) (4)
AUTIIORISED: t
SOP No. 8-06 Is,,e 3
45
APPENDIX C
(b) (4) (b) (4)

1 10 SI()I \(ABi De~~~~~~~~~~~~~~~~~~v~~~~~
RE; 9998-00-102
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MATL[ C
+2
C.
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MAENUK
~Z'14___
.L__
(b) (4)
AUTHORISED:
46
APPENDIX C (b) (4)

*
Dea
O i.\13'l1. S;i'ECIFICA1I >

____
(b) (4)
LABEL- INNER
qEF9998-00-102
9 jL,1J12345678 .2003-09
s'TERI-"-
DePuy ASRTM
TAPER SLEEVE ADAPTOR
12)14~~~~1 7 +2 TAPER
RACCORD MANC44ON COMOQUE 12j14 CONE .2 STERILE SAUF SI OUVERT OU ENDOMMAGE KONISCHER HULLEN.ADAPTER 12114 KONUS "2 ODER SESCHAEDIrT NUR STERIL WENN NiCIT GEOEr;NET TAPSE MANCHETADAPTER 1214 CONISCH +2 STERIEL TENZIJ GEOPEND OF SESCHADIOD AQTTATORE RASTREMATO DEL COLLO 12,14 CONO +2 STERILE SE NON APERTO 0 DANNEGGIATO ADAPTADOR DE VAINA CCNICA 12114 CONOI2 ESTERIL SALVO ASIERTO 0 OAfJADO AOAPTADOR DE MANGA t&NICO 12114 CONE .2 OU DANIFICADO ESTERIL A NAD SER QUE ABERTO
12;14
T ~;;:'1;30T Endar ld De~~uy ;;-V LIZ StAr.Id'VISR NPll 0~~~~~~c~
0C136-
LABEL - OISTRIBUTION & PATIENT

REF
9998-00-102 FL.o"T" 123458789 , DePuy ASR M TAPER SLEEVE ADAPTOR

T
2003-09
7..14,TAPER
I11,1ttlit 11111111111It
(b) (4)
410~
~~ ~
~~~~~~~4
SOP No. 8-06 IssueS3
AUTHORISED:
47
Previously Cleared
Ultima Unipolar Labels
A+H441852623
1
*+$AAAAAAO@OGJf
C l1!!L
Il
2004-,3
ULTIMA*12MM EXT UNIPOL AOAP SL
KM85-2623
AAAAAAOOO
MFG: DEPUY ORTHOPAEOICS INC EAaTI4- LI'

EU EpUy ORTHOPAEDICS . ST RHIHOHVS ~004
p.O. BOX 906 LEEDSLSI1 DOTEHGLAND
46581
tAQSA4.IN +44(1131270 0461
643) U 800 3a6-
I IIDIIIIIU111II111tllVIllhllIIHIhII0 IIIlll IIh~llID IlhhlIl
0+$AAAAAeOe@J0 MinLI CI
I+H441852623
1-0
KM85-2623
ULTIMA*12MM EXT.UNIPOL ADAP EL
2004-03
Io
AAAAAAOOO
MFOz DEPUY ORTHOPAEDICS. INC

DEPUH CRTHOPAEOICS-[HCP.O. BOX 888 DEPU ]HTERHA4TTOHALLID 51 AHTHOI'S ROAD
U1BOE 36G-0143 )
.ARSA. IN 46561
LEEDSLI] BIT ENGLAID 444(1I3)270461
0 DeR~ 1 -2623 SLEEUE [
MMSTyE
fljAAAAAAOee
ULTIMA
ADAPTER
-[111013
+ m12
48
Previously Cleared
U Labels
+H4485262CEz
0086
MAITL IC
ULTIMA GRAM EXTAJNIPOL ADAP DL
Ca 0
rIA
I
____
- 2622
[M
AAAAAAOOO
MFG: DEPUY ORTHOPAEDI CS, INC.

DEPUM ORtHOPAEDTCS. INC, P.A HO O 4ARS'A'i 'IN 49581
1 0 3SG-8143) DEPUY INTERNA11TIONAL LTDT
ST AN HNY'S OAD
LEEDS: SIt SODT ENGLAND
'44(I 3)270 04 1
ULTIMAG'MM FIETUNIPOL ADAP 81 60 5-2622 K AAAAAAOOO MFG: DEPUY ORTHOPAEDICS. INC

DEPUY ORTHOPAEDICS. INC. P.O.5255S WARSAW INM41501 0 1-13 DEU INTEQNATOL AINHOYSOA
LID
200f0
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LEEDS LSLI O DTtENGLAD
4) ll31270
8491
0 De~jy,,
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ADAPTER SLEEUE
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49
Previously Cleared
Ultima Unipolar Labels
,+H441852621
lY,
.+$AAAA000BH.
I"~tL IC
j
2e64-e3 I
ULTIMA*OMM EXT. UNIPOL ADAP SL

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go 1 5 IS DEPUY ORTHOPAEDICS. INC.
MFG: AL ]H4TEDNATIO LTD
O(PU .] Epu OQTHOPAED]CS IC. p.o. IoxC gee IN U*RRSPA, 4G581 C1 890 366-0143)
SI RNTHOH'S ROAD L LEEDSSII ODI ENGLAND D13)2?0 645G '44(
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MFO: DEPIJY ORTHOPAEDICS. INC.I

INT[I0HAT[OI~L LTID
DEPU ORTXOPlAEDICS INC.
DEpUY QIND~[ ST RNNTONY'S gee
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LSXG eDT ENGLAND 45501 U*OISAU, IN- 8 *4E1
,411?e7 (1 Bee 35G 143)
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RAF-PTER SLEEVE
35
50
EXHIBIT 4
Test Reports
51
Index of Test Reports

(b) (4)
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17.
151/03 045/03 143/02 283/02 284/02 043/03 128/03 032/03 044/03 307/02 006/03 299/02 037/03 145/03 141/03 082/03 065/03
52
I
4b: Test report
RESEARCH DEPARTMENT REPORT
4b: Test report
4b: Test report
4b: Test report
( b ) ( 4 )
4b: Test report
4b: Test report
4b: Test report
4b: Test report
I
4b: Test report
RESEARCH DEPARTMENT
REPORT
4b: Test report
4b: Test report
4b: Test report
.5
~~
s
4b: Test report
=-
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
~~~
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
~~~~~
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
206
4b: Test report
4b: Test report
~~~~
~~~
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
~~
4b: Test report
4b: Test report
4b: Test report
4b: Test report
~~
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
134
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
26
4b: Test report
4 b : T e s t r e p o r t
4b: Test report
4b: Test report
4b: Test report
4b: Test report
~~~
4b: Test report
4b: Test report
4b: Test report
4b: Test report
~~
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
~~~~
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
184
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
4b: Test report
~~~ ar
4b: Test report
4b: Test report
EXHIBIT 5
HA Coating/substrate
Manufacturing Information
194
(b) (4)
Office of Device Evaluation Document Mail Center HFZ-401 Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850 U.S.A.
our reference
your reference
24 February, 2004
subject
Letter of Authorization for Access to MAF (b) (4)
Dear Sirs, We would like to herein request that you grant access by reference to the above mentioned Master File to DePuy Orthopaedics, Inc., located at 700 Orthopaedic Drive, Warsaw, Indiana 46581-0988. DePuy Orthopaedics, Inc. will be using the Master File in support of their submissions to the Agency related to our hydroxy
(b) (4)
We thank you in advance for your cooperation. Best regards,

(b) (4)
Managing Director
195
RAW MATERIAL SPECIFICATIONS '*i~i~'"&'? "

(b) (4)
~"" "~
~"
(b) (4)
196l
196
RAW MATERIAL SPECIFICATION

(b) (4)
197

(b) (4)

(b) (4)
199
EXHIBIT 6
Predicate Device
510(k) Clearance Letters
200
OCT 1 320
SUMMARY OF SAFETY AND EFFECTIVENESS NAME OF FIRM: DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988 Cheryl Hastings Director, Regulatory Affairs
Koozggs
510(k) CONTACT: TRADE NAME: COMMON NAME: CLASSIFICATION: DEVICE PRODUCT CODE: SUBSTANTIALLY EQUIVALENT
DEVICES:
DePuy Pinnacle Metal-On-Metal Acetabular Cup

Liners
Acetabular Cup Prosthesis 888.3330 Hip joint metal/metal semi-constrained, with
an uncemented acetabular component, prosthesis
87 JDM
DePuy Ultima Metal-On-Metal Acetabular Cup
DEVICE DESCRIPTION AND INTENDED USE:

The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner is a metal liner that is
intended for use with the Pinnacle Acetabular Shells that have been cleared previously. The liner has a 28mm inner diameter and is offered in a neutral style only. The Pinnacle MOM liner is mechanically locked with the shell via a taper junction, and articulates with commercially available prosthetic femoral heads. It is indicated for use as the acetabular component in total hip replacement procedures for
patients suffering severe pain and disability due to structural damage in the hip joint from
rheumatoid arthritis, ostecoarthritis, post-traumatic arthritis, collagen disorders, avascular
necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for
patients with congenital hip dysplasia, protnssio acetabuli, slipped capital femoral epiphysis
and disability due to previous fusion, where bone stock is inadequate for other reconstruction
techniques.
The Pinnacle Metal-On-Metal Acetabular Cup Liners are intended for use with DePu,
Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Pinnacle Metal-On-Metal Acetabular Cup Liners are nearly identical to the Ultima
Metal-On-Metal Acetabular Cup Liners that were cleared previously. The intended use,
articular surface, material and locking mechanism with the outer shell are the same. The
only changes are minor design changes that allow the liners to be used with the Pinnacle
Acetabular Shells that have been cleared previously.
0000004
201
DEPART7MENT OF HEALTH & HUMAN SERVICES
OCT i 3 2f
Food and Drug Administration 9200 Corporate Boulevard

Rockville MD 20860
Ms. Cheryl K. Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 Re: K002883 Trade Name: Pinnacle Metal-On-Metal Acetabular Cup Liners Regulatory Class: III Product Codes: JDM and KWA Dated: September 13, 2000 Received: September 15, 2000 Dear Ms. Hastings: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for theindicationswfor me stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have-beenqeoomesifedin accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the-Act.4:honea control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandingand adulterationt If your device is classified (see above) into either class II (Special Controls) or classJLl (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Partis404teo95. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS)for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
202
Page 2 - Ms. Cheryl K. Hastings If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note thenegulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fdagov/cdrh/dsmamain.html". Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure
203
510(k) Number (if known) KI_6
__
Device Name DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners Indications for Use: The Pinnacle Metal-On-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to st-uctural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic artifis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previouwslion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Metal-On-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.
(Division Sign-Off) Division of General Restorative Devices 0-zW~ 4 510(k) Number Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
0000005
204
I)EPAHTMI.ENT Of HEALTH & HUMAN SERVICES
Pubhc Healtr Service
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0000004
207
JUL 1 2002
WRIGHT
MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD

ARLINGTON, 901-867-9971 TN 38002
510(K) SUMMARY
OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Metal TRANSCEND Articulation System. Submitted By: Date: Contact Person: Proprietary Name: Common Name: Classification Name and Reference: Wright Medical Technology, hic. April 26, 2002 Ehab M. Esmail Manager Regulatory Affairs Metal TRANSCEND Articulation System (LARGER SIZES) TOTAL HIP SYSTEM 21 CFR 888.3320 Hip joint metal/ metal semiconstrained, with a cemented acetabular component prosthesis - Class III 21 CFR 888.3330 Hip joint metal/ metal semiconstrained, with an uncemented acetabular component prosthesis - Class III Orthopedics/87/KWA
Device Product Code and Panel Code: DEVICE INFORMATION A.
INTENDED USES/ INDICATIONS The Metal TRANSCEND Articulation System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis;
510(K) SUMMARY
WRIGHT
208
TRANSCENDTM Arniculaton System

510(K) SUMMARY
Page 2 of4
3. correction of fimctional deformity; and, 4. revision procedures where other treatments or devices have failed The Metal TRANSCEND Articulation System components are for single use only. B. DEVICE DESCRIPTION
The previously submitted and cleared
Metal TRANSCEND Articulation System (Exhibit 1: 510(k) K004043) is composed of two pieces, a metal shell and a metal liner that mates to the shell by the use of a taper locking mechanism. This two piece design limits the size of the femoral heads. The use of a monoblock superfinished shell allows larger head sizes to be used. The new Metal TRANSCEND Articulation System (larger sizes) should increase the range of motion and decrease the risk of dislocation as compared to the current TRANSCEND (510(k) K004043) Metal on Metal bearing couple. The Metal TRANSCEND Articulation System (larger sizes) consists of the following components that are substantially equivalent to the previously cleared components submitted under the Metal TRANSCEND Articulation System (510(k): K.004043): metal monoblock acetabular shells, and metal femoral heads. Design features of the Metal TRANSCEND Articulation Monoblock Shell (larger sizes) are summarized below: Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75 Porous coated with CoCrMo (ASTM F75) Sintered beads * Available sizes: ranging from 46mm to 64mm (outer diameter) in 2ram increments (The inner diameter of each shell is 10mm smaller than the outer diameter) * The articulating surface of the implants will be superfinished (1 microinch Ra maximum) to insure form tolerance and a fine surface finish * A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum while removing very little bone to accommodate a larger Femoral Head. Design features of the Metal TRANSCEND Femoral Head (larger sizes) are summarized below: Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75 Available sizes: 38rmm, 40mm, 42mm, 44mm, 46mm, 48mm, 50mm, 52mm, 54mm * Available neck lengths: -3.5, 0, +3.5 The articulating surface of the implants will be superf'mished (I microinch Ra maximum) to insure form tolerance and a fine surface finish The taper connection for the Metal TRANSCEND Femoral Heads (larger sizes) will be identical to the Metal TRANSCEND Femoral Heads (510(k):K004043) and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.
5JO(K) SUML4RY
WRIGHT
209
TRANSCENDTM Articulation System 510(K)SSUMMARY Page 3 of4
C.
MATERIALS
The materials used for the Metal TRANSCEND Articulation System (larger are substantially equivalent to competitive devices previously cleared for market. sizes) Monoblock Acetabular Shells
Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75)
*
Porous coated with CoCrMo (ASTM F75) Sintered beads Femoral Head * Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75)
D. CLINICAL DATA
The intended use, material, design features, type of interface, and reported ware rates of the Metal TRANSCEND Articulation System (larger heads) are substantially equivalent to the previously submitted and cleared Metal TRANSCEND Articulation System (510(k): K004043). Therefore, Clinical success similar to that of the previously cleared components submitted under the Metal TRANSCEND Articulation System (510(k) K004043) is expected. The clinical data (TRANSCEND Metal Articulation System Controlled Clinical Trial in support of 510(k) Statistical Analysis Report Version 8.0 December 23, 2000- Volume 1 & 2) was previously submitted under the Metal TRANSCEND Articulation System (510(k) K004043). The data was collected prospectively from multi-sites. After excluding a single site with significantly poorer survival than all other sites that was identified as having problems with surgical technique, 2-year cumulative survival was found to be clinically equivalent to (no worse than) the Dobbs metal on metal cohort. Nearly 90% of procedures resulted in "at least good results" at 1 and 2 years as determined by the Harris Hip Score, results that compared favorably with literature-based cohorts of THR. There was more than a 50% increase in the SF-12 physical function component score. Complications and adverse events were rare. Radiolucencies >2amm were rare. There were no findings of subsidence of the stem or migration of the cup >2mim. In conclusion, this controlled clinical trial provides substantial evidence that the Metal TRANSCENDTm Articulation System (larger sizes) is as safe and effective as approved predicate devices with clinically equivalent patient outcomes relative to such devices, thus supporting a 510(k) claim.
SI 0(K) SUMMARY
WRIGHT
210
I RANSCENDTM Articulation System 5 10(K) SUMMARY Page 4 of 4
E.
SUBSTANTIAL EQUIVALENCE INFORMATION The intended use, material, type of interface, and design features of the Metal TRANSCEND Articulation System are substantially equivalent to the competitive devices. The safety and effectiveness of the Metal TRANSCEND Articulation System are adequately supported by the substantial equivalence information, materials data, testing results, and clinical data provided within this Premarket Notification.
o0(K) SoIMAAY
WRIGHT
211

'%%,,,4
Mr. Ehab M. Esmail

Mariager Regulatory Affairs
Wright Medical Technology
5677 Airline Road
Arlington, Tennessee 38002
JUL 1 2002
Re: K021349
Trade Name: Metal TRANSCEND' Articular System (Larger Sizes)
Regulation Number:
21 CRF 888.3320 and 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and Hip joint metal! metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III
Product Code: KWA
Dated: April 26, 2002
Received: April 29, 2002 Dear Mr. Esmail: We have reviewed your Section 510(k) premarket notification of intent referenced above and we have determined the device is substantially to market the device equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application therefore, market the device, subject to the general controls provisions (PMA). You may, of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
212
Page 2 - Mr. Ehab M. Esmail This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a claissification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for invitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number
(800) 638-2041 or (301) 443-6597 or at its Internet address Sincerely yours,
SCe a Witte, Ph.D MD. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure
213
WRIGHT
MEDICAL TECHNOLOGY, INC. 5 5677

ARLINGTON,
901-867-9971
AIRLINE
TN
ROAD
38002
Metal TRANSCEND Articulation System INDICATIONS STATEMENT

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved
hip function in skeletally mature patients with the following conditions:
1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2) inflammatory degenerative joint disease such as rheumatoid arthritis;
3) correction of functional deformity; and,
4) revision procedures where other treatments or devices have failed.
(iiionSinOt Division of General, Restorative and Neurological Devices 510(k)Number KOZ t(Z'?
INDICATIONS STATEMENT
'WRIGHT
214
cuiflt AND RA~~rnwtfltflwAYai~f

iouIfl~~rcas
FDA Home Page I CDRH Home Page I Search I CDRH A-Z Index I Contact CDRH 5I Registration
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510(k) Premarket Notification Database Device Classification Name 510(K) Number Regulation Number Prosthesis, Hip, Hemi-, Fmrl ea Femoral, Metal K965156 888.3360 Ultima*Unipolar Head And Adapter Sleeves Johnson & Johnson Professionals, Inc. 325 Paramount Dr. Raynham, MA 02767 0350 Sally Maher KWL
12/23/1996
Contact Product Code

Date Received
Decision Date Decision Classification Advisory Committee Review Advisory Committee Statement/Summary/Purged Status Summary Type Reviewed By Third Party Expedited Review
01/24/1997 Substantially Equivalent (SE) Orthopedic Orthopedic Summary Only Summary Traditional No No
Database Updated 2/06/2004
CDRH Home Page I CDRH A-Z Index I Contact CDRH IAccessibility I Disclaimer FDA Home Page I Search FDA Site I FDA A-Z Index I Contact FDA I HHS Home Page
sic
2/24/2004 215
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pnm.cfm?ID=95094
Summary of Safety & Effectiveness Data for the ULTIMA* Unipolar Head and Adapter Sleeves
Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
].
Contact Person Johanna Newman, Assoc. Regulatory Affairs Specialist, (508) 828-3268. 2. Device Name Proprietary Name: Common Name: Clausifiatsn Name: Regulatory Clam: Product Code: Owner/ Operator N 3. Device Classification Classification for ULTIMA* Unipolar Head and Adapter Sleeves has been placed in Class 11 by
21 CFR 8.3360
4. Statement of SubstantIal Equivalence The safety and effhctivcness of the ULTIMA* Unipolar Head and Adapter Sleeves is substantially equivalent in tus of fiuncti to the Johnson & Johnson ULTIMA* Unipolsr Modular Head and the Hownmdica Uniurax Unipolar System. Furthermore, analysis reults demonstrate that the ULTJMA* Unipolar Head and Adapter Sleeves meets the set criteria for the establishment of "substantial equivalence". 5. Indications for Use The ULTIMA* Unipoclar Had is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to:
I. femoral neck fseture, 2. avascular necrosis of the femoral head, 3. osteoarhritis, 4. abnormalities where: * the major pathology affects the femoral head, * the acetabular cavity is normal and not deformed or weakened, * acetabular replacement is not required or desirable.
-
'
g ..
-:'
JAN 24 997
ULTIMA* Unipolar Head and Adapter Sleeves

Hip joint femoral (hemi-hip) metallic cemented or
uncemented prosthesis
Prosthesis, Hip
Class HI y 21 CFR 888.3360
b 87 1DG
9001269
f2
216
6.
Physical Description The ULTIMA* Unipolar Head is provided in a size range of 38mm to 63mm (outer diameter), in Imm increments. Sizes from 44mm through 63mm are manufactured as a twopiece assembly. The two pieces are made of cast cobalt-chrornium-molybdenum alloy conforming to ASTM 1:75. Both pieces are treated with hot isostatic pressing and solution annealing. The two cast pieces are machined and then joined permanently by electron beam welding to form a hollow unipolar head. Sizes from 38mm through 43mm are cast from cobalt-chromium-molybdenum alloy as a solid head, and are isostatic pressed and solution annealed before machining. Both ofthese size ranges are finish machined to the outer diameter size. The outer diameter is highly polished for articulation with the implant recipient's natural acetabulum. The ULTIMA* Unipolar Head has a tapered bore which can receive a variety of Adapter Sleeves. The adapter sleeves can be tapered on the outside to the mate with the unipolur head, and tapered on the inside to mate with the appropriate femoral stem trunnion. The adapter sleeves are available in a 10/12 taper, in size increments for -3rmm, +0mm, +5Srm. and +10mm neck lengths; in a 11/13 taper, in size increments for +0mm, +6mm, and + 12mm neck lengths; and in a 12114 taper, in size increments for +0rnm, +3.5mm, and +7mm neck lengths. The adapter sleeves are machined from cobalt-chromium-molybdenum alloy in wrought bar form conforming ASTM F799.
Table 1. Similarities and Difference Matrix ULTIMA* Ualpelar

Head and Adapter
ULTIMA* Ualpelar
Modular Head
Howmedlea Unfiax
Unipolar System
DESIGN
: I__________ No (ten maemmeets) (1mm Adapter sleeve for Yes

increased
neck kno
Range of sizes
3Imm-63ram
3Smm-6Smm
increments)
O(me
3Smm-6Smm increments)
Yes
Number neck length sizes
1O/12 taper -3m.

+4Ovm +Sram,+l0m
+0nmm +5ram
11/13 tape. +Omm,

+6mm, +12mm
-4mm, +Ommn, +5mm.

+10mm
12/14 taper.+fmm
+3.5mm, +7rmn
Morse-taper locking
Yes
Yes
Yes
mechanism to
modular fermor stem
Pai hal i MATERIALS
ceilMet
Yes
Yes
Yes
Manufactured from Co-Cr-Mo
Ye
Yes
12
217
& HUMAN SERVICES DEPARTMENT OF HEALTH
Public Health Service Food and Drug Administration Memorandum
From: Subject: To:
Reviewer(s) - Name(s) 5 10(k) Number
- x e E2T h
-r w
that the subject 510(k) Notification: The Record It is my recommendation
B] Refused
to accept.
B Requires additional information (other than refuse to accept).
12is substantially equivalent to marketed devices.
devicdr.
ONOT substantially equivalent to marketed a device, duplicate, etc.).
B]Other (e.g., exempt by regulation, not Surveillance? Is this device subject to Section 522 Postmarket Is this device subject to the Tracking Regulation? of this 510(k)? Was clinical data necessary to support the review Is this a prescription device? Was this 510(k) reviewed by a Third Party? Special 510(k)? on H Drive 5lOk/boilers Abbreviated 510(k)? Please fill out form Enclosed Truthful and Accurate Statement B Requestedtl statement S1A 510(k) summary OR
B]A 510(k) for class III devices
IS
The required certification and summary ]The indication for use form
see algorithm on H drive 51 Ok/Boilers) Combination Product Category (Please Animal Tissue Source [] YES
BYES
EBYES BYES RIYES BYES BYES B-YES
Nf NO 1j~ NO [ NO
El
[
NO NO NO
U NO
0] NO
Material of Biological Origin
Bl
YES
NO
807.95 (doesn't apply for SEs): The submitter requests under 21 CFR exceeding 90 days B Confidentiality for 90 days B] Continued Confidentiality Bl No Confidentiality (optional):
Additional Product Code(s) with panel Predicate Product Code with class:
Final Review:
(DivisionDirector)
Revised:4/2/03
"SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION
K040627
Reviewer: Elizabeth L Frank Division/Branch: D.GRND/OR.DB Device Name: DePuv ASR m Modular Acetab~ular Cu Sy~stem Product To Which Compared (510(K) NumberIf Known): K965156. K002883. K003523, K021349 YES NO 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Is Product A Device Is Device Subject To 5 10(k)? Same Indication Statement?
Do Differences Alter The Effect Or Raise New Issues of
Safety Or Effectiveness?
Same Technological Characteristics? Could The New Characteristics Affect Safety Or Effectiveness?
Descriptive Characteristics Precise Enough? New Types Of Safety Or Effectiveness Questions? Accepted Scientific Methods Exist? Performance Data Available? Data Demonstrate Equivalence? X x X X
-X
ITNO f If NO If YES If YES If YES If YES

=
tp Stop
= =
X X
Go To 5
Stop NE
Go To 7 Go To S
If NO = Go To 10
If YES = Stop SE
If YES If NO
=
Stop NE NE
=Stop
INO=Rquest Data Fia ecision: SE
Note: In addition to completing the form on the LAN, "yes" responses to questions 4, 6, 8, and I11, and every "no" response requires an explanation.
K040627/S2
l. Intended Use: The DePuy ASRTM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. 2. Device Description: The acetabular component is designed as a cast CoCrMo alloy (ASTM F-75) one-piece cup with Porocoat porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shell has a highly polished, superfinished internal bearing surface, and is available with outer diameter sizes 44-70 mm in 2mm increments with inner diameters ranging from 39-63mm. There is no separate liner component to this system, as it is a one-piece acetabular shell used with a unipolar femoral head and a taper sleeve adapter. The uni femoral head is manufactured from cast high carbon CoCrMo alloy (ASTM F-75) and is available in a range of diameters from 39-63mm in 2mm increments. All of the uni femoral heads have an internal taper which mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13 tapers corresponding to the external tapers on DePuy femoral stems. The femoral heads have a highly polished, superfinished exterior bearing surface, and articulate with corresponding one-piece metal acetabular cups. The sponsor states that the material, outer diameter, clearances and surface finishes of the (b) (4) (b) (4) ) are identical to the subject unipolar femoral head. The diametrical clearances for all (femoral heads to acetabular cups) range from 100-170 microns. femoral implants The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity of using taper sleeve adapters in two taper options allows for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems. The ASR 12/14 taper sleeve adapters are manufactured from forged cobalt-chrome-molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters are manufactured from wrought CoCrMo alloy and were previously cleared in the Ultima Unipolar Head and Sleeve (K965156) and are offered in neck length options of +0, +6, and +12. EXPLANATIONS TO "YES" AND "NO" ANSWERS TO QUESTIONS ON PAGE 1 AS NEEDED 1. Explain why not a device: Explain why not subject to 510(k): 2. How does the new indication differ from the predicate device's indication: 3. Explain why there is or is not a new effect or safety or effectiveness issue: 4. Describe the new technological characteristics: 5. Explain how new characteristics could or could not affect safety or effectiveness: 6. 7. Explain how descriptive characteristics are not precise enough: Descriptive characteristics are not precise enough because the sponsor must demonstrate that the new material, larger diameters and larger diametrical clearances produce less wear than the predicate metal-onmetal systems. 8. 9. 10. 11. Explain new types of safety or effectiveness questions raised or why the questions are not new: Explain why existing scientific methods can not be used: Explain what performance data is needed: Explain how the performance data demonstrates that the device is or is not substantially equivalent: The performance data demonstrated that the subject device produces less wear than the predicate device. Please see Summary for more detailed information.
K040627/S2
INTERNAL ADMINISTRATIVE FORM:

YES 1. Did the firmrequest expedited review? 2. Did we grant expedited review? 3. Have you verified that the Document is labeled Class III for GMP purposes? 4. If, not, has POS been notified? 5. Is the product a device? 6. Is the device exempt from 510(k) by regulation or policy? 7. Is the device subject to review by CDRH? 8. Are you aware that this device has been the subject of a previous NSE decision? 9. If yes, does this new 510(k) address the NSE issue(s), (e.g., performance data)? 10. Are you aware of the submitter being the subject of an integrity investigation? 11. If, yes, consult the ODE Integrity Officer. 12. Has the ODE Integrity Officer given permission to proceed with the review? (Blue Book Memo #I91-2 and Federal Register 90N0332, September 10, 1991. NO X
N/A N/A
X
N/A X
N/A N/A
K040627/S2
510(k) REVIEW MEMORANDUM
To: From: Date: Device:
Company:
Contact:
K040627.S2 Elizabeth Frank, Biomedical Engineer, M.S. FDA/CDRHIODE/DGRND/Orthopedic Devices Branch (HFZ-410) August 3, 2005 DePuy ASRTM Modular Acetabular Cup System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component prosthesis Product Code: 87 KWA; Class III DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Warsaw, IN 46581-0988 Natalie Heck, Manager, Regulatory Affairs Phone: 574-372-7469, Fax: 574-371-4939, Email: nheckidpn/us.ini.com
Ck) La.
//
Recommendation: The intended use, material, and design features of the DePuy ASRTM Modular Acetabular Cup System are Substantially Equivalent (SE) to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Line (K002883, K003523) and the Biomet M'aTM System (K993438, K002379, K003363, KOI 1110, K042037). Review: 1. Administrative Requirements: The submission contains a 510(k) Summary, a Truthful and Accuracy Statement, Indications for Use page and Class III Certification and Summary. Device Description: Acetabular Shell: The acetabular component is designed as a cast cobalt-chrome-molybdenum (CoCrMo) alloy (ASTM F-75) one-piece cup with Porocoat porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shell has a highly polished, superfinished internal bearing surface, and is available with outer diameter sizes 44-62 mm in 2mm increments with inner diameters ranging from 3955mm. There is no separate liner component to this system, as it is a one-piece acetabular shell used with a unipolar femoral head and a taper sleeve adapter. The acetabular shell is identical to the (b) (1) (A) ( In Amendment 1, dated 8/1/05 the sponsor b components (57, 59, 61, and 63mm) from this submission. has withdrawn the largest size ) ( predicate DePuy Pinnacle metal-on-metal (MOM) system (K003523, K002883) is designed as a The 1 CoCrMo alloy (ASTM F-1537) superfinished metal liner that assembles into a porous coated, wrought ) metal shell. The titanium aluminum vanadium (Ti-6A1-4V) alloy acetabular cup is a titanium alloy with three dome screw holes, an apical hole used for stepped and porous-coated shell ( hemispherical metal insert mechanically locks with the metal shell via a visualization, and a peripheral female taper. The A ) taper junction. The Porocoat porous coating on the shell is commercially pure titanium. The Pinnacle MOM liner is available in 28 or 36mm inner diameter options, for use with corresponding 28 & 36mm CoCrMo metal femoral heads.
2.
K040627 Pg. 1 of 30
Porocoat Coating: The subject shell component uses the same PorocoatV process used for the predicate device (K002883 & (b) (4) K003523). The coating consists of 1 includes a summary of the properties of the PorocoatO porous (b) Table (4) coating: (b) (4)
Hydroxyapatite Coating: crystalline hydroxyapatite (HA) coating. The outer surface of the cup has the addition (b) (4) Master substrate are found in (b) (4) Characteristics of the HA coating on the CoCrMo Porocoat (PO4)30H) ceramic. (b) (4) The HA material conforms to ASTM F1185-88 for hydroxyapatite (Ca 5 Given the crystalline nature of the HA coating and the strength of attachment to the porous surface, the sponsor does not feel there is a well-developed mechanism of particulate release from the shell OD into the periarticular tissue or synovial fluid to subsequently migrate into the articular surface. In the situation where an HA particle would potentially be released from the acetabular shell and migrate into the articular region, it would likely be very small in order to advance into the metal-on-metal articular space (less than 80-190 microns, for ASR articular surfaces). Alternatively, if the particle were larger than the clearance between the articular surfaces maintained by the fluid film lubrication regime and became trapped within the articular surfaces under the circumstances of microseparation, the sponsor believes that several things would occur: * The very hard surfaces of the CoCrMo alloy would crush the weaker and brittle HA particle creating much smaller sub-micron size particles allowing them to float freely out of the surface and become resorbed by the body fluids. If a larger HA particle were to scratch the articular surface, the sponsor believes it would be fractured and washed free of the articular surfaces and the scratch would eventually repolish as metal-on-metal heads are known to do.
From the known clinical experience and laboratory testing the sponsor does not believe that these particles would cause degradation to the surface of the two hard, metal surfaces. We have previously allowed the addition of HA coating to metal-on-metal acetabular shells, therefore since the sponsor has addressed this concern, this is acceptable. Femoral Head: The uni femoral head is manufactured from cast high carbon cobalt-chromium-molybdenum (CoCrMo) alloy (ASTM F-75) and is available in a range of diameters from 39-55mm in 2mm increments. In Amendment 1 dated 8/1/05, the sponsor has withdrawn the largest size components (57, 59, 61, and 63mm) from this submission. All of the uni femoral heads have an internal taper, which mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13 tapers corresponding to the external tapers on DePuy femoral sterns. The femoral heads have a highly polished, superfinished exterior bearing surface, and articulate with corresponding one-piece metal acetabular cups. The sponsor states that the material, outer diameter, (b) (4) clearances and surface finishes of the K040627 Pg. 2 of 30
(b) (4) are identical to the subject unipolar femoral head. The predicate DePuy Pinnacle system (K003523, K002883) is composed of wrought Co-Cr-Mo alloy (ASTM F-1537) and comes in sizes of 28 or 36mm. The sponsor compares their femoral heads to the Wright Medical TRANSCEND Articulation System. Both devices are supplied in large diameter sizes (subject device: 39-55mm and Wright: 38-54mm). Both devices are manufactured from cast high carbon CoCrMo alloys conforming to ASTM specifications and articulate with a one-piece CoCrMo alloy acetabular shell. Articulating surfaces of both the uni femoral head and one-piece acetabular cup are super finished to ensure proper tolerances. Taper Sleeve Adapters: The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity of using taper sleeve adapters in two taper options allows for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems. The ASR 12/14 taper sleeve adapters are manufactured from forged cobalt-chrome-molybdenum (CoCrMo) alloy. The taper connections are based upon the design used for the adapter sleeves described in the DePuy Ultima Unipolar Adapter Sleeves (K965156). The 12/14 taper sleeve adapters are offered in neck length options of+l.5, +5, and +8.5. The 11/13 taper sleeve adapters are manufactured from wrought CoCrMo alloy and were previously cleared in the Ultima Unipolar Head and Sleeve (K965156) and are offered in neck length options of +0, +6, and +12. A list of all sizes of the DePuy ASRTM Modular Acetabular System is included in Amendment 1 with a list of compatible components in Exhibit 1. The sponsor states this is "a representative sample of taper adapter M T sleeve and femoral stem compatible components for the DePuy ASR Modular Acetabular System, and should not be taken as a complete listing. Femoral stem compatible components are limited to stems manufactured of Cobalt Chrome Molybdenum alloy or Titanium alloy, and having taper sizes of 11/13 or 12/14. This limitation corresponds to the listed taper sleeve adapted styles manufactured from Cobalt Chrome alloy. Device photographs are included on page 13 and engineering drawings are provided in Exhibit 2. The taper sleeve adapter drawings are included on page 13 of Supplement 1. Material: The subject system is composed of cast high carbon cobalt-chromium-molybdenum (CoCrMo) alloy (ASTM F-75). ASTM F-75 requires the carbon content of the CoCrMo casting alloy material be within the range of 0-35%. The internal material specification for the subject ASRTM uni femoral head and cup Adherence to this internal specification specifies a carbon content within the range of (b) (4) of the range required by the the device will have a carbon content within the (b) (4) guarantees ASTM specification. The sponsor believes material combination (wrought or cast) is insignificant providing the conditions of elastohydrodynamic lubrication have been achieved through the design parameters of surface finish, form, diametrical clearance and the use of large diameter heads. Test Report RDR 143/02 (Exhibit 4, Index 3) (b) details the work done to compare ( (4) in The internal raw material specification for the wrought CoCrMo alloy requires a carbon content b the range (b) ) The carbon content of the cast CoCrMo alloy is specified to a of (b) (4) (4) ( (b) of the ASTM specification. the sponsor concludes that4there is no (4) Based on the carbon content requirements and testing performed, ) increase in safety concerns based upon the change from wrought CoCrMo to cast CoCrMo for the ASR uni head and cup bearing couple. Diametrical Clearances: The diametrical clearances for all femoral implants (femoral heads to acetabular cups) are provided in Table 2 below. The sponsor has withdrawn the largest size components (57, 59, 61, and 63mm) from this submission, so they were removed from the following table. K040627 Pg. 3 of 30
Table 2. DiametricalClearances (b) (4)
In Supplement 2, the sponsor has provided a comparison table (Table 3) of previously cleared diametrical clearances. The first DePuy Metal-on-Metal Hip System was the Ultima Metal-On-Metal Acetabular Cup (b) (4) (28mm) cleared in K001523. (b) (4) . In Exhibit 4 of K002883, the sponsor provides a comparison chart identifying that the diametrical clearance for the predicate Ultima and the 28mm Pinnacle system are identical, ranging from 40-80pm. In K003523, the Pinnacle system was expanded to include 36mm liners. The comparison chart of the 28mm and 36mm Pinnacle liners (K003523, Exhibit 4) indicates the 28mm and 36mm liners have identical diametrical clearances (40-80pm). However, the sponsor has indicated in the subject submission that the . On 7/12/05 the sponsor was contacted by telephone to clarify 36mm liners have a (b) (4) the diametrical clearance of the 36mm system. The sponsor discovered the chart in Exhibit 4 of the predicate device is incorrect. According to the engineering drawings of K003523 the Pinnacle 36mm (b system has a ) (4 According to current practices in ORDB the diametrical clearance of a system cannot be changed without ) clinical data. Therefore, given this new information the Pinnacle 36mm system may not have been cleared in 2000. However, after searching the Medical Device Reporting Program (MDRs) for adverse events associated with the Pinnacle 36mm liners, only 5 adverse events were reported. Three of these adverse events were failure for the liner and shell to line up appropriately, one adverse event was a patient revised due to pain and one adverse event gave no details. Over the same period of time, the comparable Sulzer metal-on-metal system had approximately 25 adverse events reported, while Zimmer had 3 reports regarding the 28mm acetabular insert and 3 reports regarding their Cobalt Chrome femoral head. Therefore, during the same time period the 36mm Pinnacle system had a reasonable number of adverse events reported. Table 3. DiametricalClearancesof Previously ClearedSystems (b) (4)
The technical justification for increasing the clearance above that of the predicate Pinnacle Metal-on-Metal (b) design has been described in test report RDR117/04, (b) (4) (4) from Supplement 1. Modem metal-on-metal where a thin layer of lubricant completely separates the head and hip implants have a fluid film lubrication K040627 Pg. 4 of 30
For cup bearing surfaces thus protecting the articulating surfaces during relative motion and reducing wear. lubrication this reason, it is important to optimize the clearance to ensure that the bearing receives adequate (b) (4) for wear reduction. Based on the (b) (4) there is no increase in safety concerns based upon the increase in diametrical clearance. Predicate Device Comparison: and The Biomet M2a M 28mm Acetabular System (K993438) had clinical data to support its safety cleared. The system was expanded to include 32mm liners (K002379) effectiveness when it was originally tolerance without clinical data. Both sizes were composed of CoCrMo per ASTM F1537, with the same between the modular heads and liners. In KO11110, the M2 aTM System was expanded bands and clearance per to include 38mm components. The 38mm acetabular cup and modular heads are composed of CoCrMo 38mm components tested minimum and maximum diametrical clearance ASTM F75. The wear test for the were (55-167 kim) to ensure the worst case was evaluated. The sponsor states clearances and sphericities predicate slightly different than the 32mm components, but the clearances were not clearly identified in the make a direct comparison. Clinical data was not provided for the change in device, so it is difficult to through material, diameter or clearance because the reviewer believed the changes could be addressed Biomet's next mechanical testing. The only testing completed was wear testing for 5.5 million cycles. submission for the M2a Magnum System (K042037) increased diameter from 38mm to 40mm-60mm. range of These components are also composed of ASTM F75. Wear testing was completed and a concerns were clearances from 106-494 gm was evaluated. Since larger diameters have lower wear rates no found with increasing diameter or altering diametrical clearances. metal-onThe sponsor explains that increasing the bearing diameter enhances the wear performance of a Therefore, the larger metal articulation because elastohydrodynamic lubrication is more easily achieved. ASR bearing diameters represent a better wear scenario than the predicate 36mm Pinnacle Metal-on-Metal and Acetabular Cup System. Additionally, larger diameter heads offer greater resistance to subluxation dislocation as well as improved range of motion. Test report RDR 117/04 (b) (4) (b) (4)
The sponsor was asked to provide more information regarding the (b) (4)
(b) (4)
systems On 7/21/05 an "Engineering Rounds" discussion was held to discuss changes in metal-on-metal hip clinical data. We discussed this file and the Wright Medical that may or may not require new CONSERVE Total Femoral Head (K051348, under review). Based on the changes that have previously DePuy been allowed with mechanical testing according to the Biomet description above, the proposed The sponsor addressed our final concern regarding frictional torque of the largest changes are comparable. see the size components by withdrawing the components over 55mm that were not evaluated. Please K040627 Pg. 5 of 30
and attached summary of the Engineering Rounds discussion. Tables 4 and 5 summarize the similarities predicate devices. differences between the subject and
3.
Intended Use:
procedures m The DePuy ASR T Modular Acetabular Cup System is indicated for use in total hip replacement the hip joint from rheumatoid for patients suffering severe pain and disability due to structural damage in of arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion with congenital hip dysplasia, slipped femoral fractures. Use of prosthesis is also indicated for patients for other capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate reconstruction techniques. Cup Liner The indications for use statement is the same as the Pinnacle Metal-On-Metal Acetabular component in total hip replacement to the entire (K003523), except it has been revised from the acetabular total hip replacement.
4.
Sterilization:
Radiation Type: Gamma Radiation Source: (b) (4) Minimum Dosage: (b) (4) Sterility Assurance Level: (b) (4) Sterility Validation Method:
(b) (4)
5.
contain the The instructions for use and draft labels are provided in Exhibit 3. The package labels package insert for the DePuy ASR Modular Acetabular Cup System appropriate information. The adverse contains all appropriate information (device description, indications, contraindications, potential and sterilization information). The sponsor also includes the events, warnings and precautions, cleaning Instructions for Use of the previously cleared Ultima Unipolar Taper Sleeve.
Labeling:
K040627 Pg. 6 of 30
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(b) (4) and these results are being used Many of the test reports were performed to support the articulation of the large diameter unipolar femoral heads and ASR acetabular cups in the subject submission. Hip joint replacement devices transmit load through the bearing surface, specifically the joint contact area. This is no difference whether the femoral component takes the form of a modular (b) (4) In laboratory testing simulation, the loading in the head and femoral stem or a contact area is affected by components of the bearing design, specifically bearing size, clearance, surface roughness and Young's modulus of the bearing material, but not by the method of fixation of the femoral (b) (4)
Testing:
(b) (4) 1. (b) (4) (b) (4) Testing:
This is acceptable.
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K040627 Page 9 of 31
(b) (4)
2. (b) (b) (4) (4)
Testing:
(b) (4) * * * *
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4b: Raw Test Data
4b: Raw Test Data
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4b: Raw Test Data
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Title: Analysis of Fluid Film Lubrication in Artificial Hip Jiont Replacements with Surfaces of High Elastic Modulus Author(s): Z M Jin; D Dowson; 3 Fisher Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine Volume: 211 Page: 247-256 Abstract: Lubrication mechanisms and contact mechanics have been analyzed for total hip joint replacements made from hard bearing surfaces such as metal-on-metal and ceramic-on-ceramic. A similar analysis for ultra-high molecular weight polyethylene (UHMWPE) against a hard bearing surface has also been carried out and used as a reference. The most important factor influencing the predicted lubricating film thickness has been found to be the radial clearance between the ball and the socket. Full fluid film lubrication may be achieved in these hard/hard bearings provided that the surface finish of the bearing surface and the radial clearance are chosen correctly and maintained. Furthermore, there is a close relation between the predicted contact half width and the predicted lubricating film thickness. Therefore, it is important to analyze the contact mechanics in artificial hip joint replacements. Title: The effect of femoral head diameter upon lubrication and wear of metal-on-metal total hip replacements
Author(s): S L Smith; D Dowson; A A J Goldsmith
Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine
Volume: 215 Page: 161-170
Abstract: It has been found that a remarkable reduction in the wear of metal-on-metal hip joints can be achieved by simply increasing the diameter of the joint. A tribological evaluation of metal-on-metal joints of 16, 22.225, 28 and 36 mm diameter was conducted in 25 percent bovine serum using a hip joint simulator. The joints were subject to dynamic motion and loading cycles simulating walking for both lubrication and wear studies. For each size of joint in the lubrication study, an electrical resistivity technique was used to detect the extent of surface separation through a complete walking cycle. Wear of each size of joint was measured gravimetrically in wear tests of at least 2x10 6 cycles duration. Joints of 16 and 22.225 nun diameter showed no surface separation in the lubrication study. This suggested that wear would be proportional to the sliding distance and hence joint size in this boundary lubrication regime. A 28mm diameter joint showed only limited evidence of surface separation suggesting that these joints were operating in a mixed lubrication regime. A 36 mm diameter joint showed surface separation for considerable parts of each walking cycle and hence evidence of the formation of a protective lubrication film. Wear testing of 16 and 22.225 nun diameter metal-on-metal joints gave mean wear rates of 4.85 and 6.30 6 mm3 /I10 cycles respectively. The ratio of these wear rates, 0.77, is approximately the same as the joint diameters ratio, 16/22.225 or 0.72, as expected from simple wear theory for dry or boundary lubrication conditions. No bedding-in was observed with these smaller diameter joints. For the 28 nun diameter joint, from 0 to 2xI06 cycles, the mean wear rate was 1.62 MM3 /106 cycles as the joints bedded-in. Following bedding in, from 2.Ox1 06 to 4.7x1 06 cycles, the wear rate was 0.54 mm~/ 10 6 cycles. As reported previously by Goldsmith et al. in 2000, the mean steady state wear rate of the 36 mm diameter joints was lower than those of all the other diameters at 0.07 mm3 /106 cycles. For a range of joints of various diameters, subjected to identical test conditions, mean wear rates differed by almost two orders of magnitude. This study was demonstrated that the application of sound tribological principles to prosthetic design can reduce the wear of metal-on-metal joints, using currently available materials, to a negligible level.
8.
Sponsor's Information in support of SE:

DePuy Pinnacle Metal-on-Metal Acetabular Cup Liner (K003523, K002883) Wright Medical Metal TRANSCEND Articulation System (K02 1349) DePuy Ultima Unipolar Head and Adapter Sleeves (K965 156)
9.
Review of other 5lO(k)s/IDEs:

Wright Medical Metal TRANSCEND Articulation System (K004043/SOO I) Corin USA Cormet Large Diameter Metal on Metal Hip System IDE (0030265) K040627
Page 28 of 31
Biomet M2a TM Acetabular System (K993438, K002379, K003363, KOI 11I10, K042037)
10.
Summary:
The acetabular component of the ASRm Modular Acetabular Cup System is designed as a cast cobaltchrome-molybdenum (CoCrMo) alloy (ASTM F-75) one-piece cup with Porocoat porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shell is available with outer diameter sizes 44-62 tur in 2mm increments with inner diameters ranging from 39-55mm. The uni femoral head is manufactured from cast high carbon cobalt-chromium-molybdenumn (CoCrMo) alloy (ASTM F-75) and is available in a range of diameters from 39-55mm in 2mm increments. All of the uni femoral heads have an internal taper, which mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13 tapers corresponding to the external tapers on DePuy femoral stems. The ASRTm Modular Acetabular Cup System is a newly designed metal-on-metal hip system with larger diameters, a different form of Co-Cr-Mo and larger diametrical clearances than their predicate Pinnacle system (K003523, K002883). They have developed a system that produces less wear than their own previously cleared Pinnacle metal-on-metal system, which had clinical data supporting its safety and (b) (4)
previously cleared metal-on-metal systems that may or may not have been supported with clinical data, please see Tables 4 and 5. ORDB has been particularly careful in regards to what changes have been allowed for metal-on-metal systems with and without the support of clinical data. Review of several predicate systems revealed that we had allowed more significant changes than realized. For example, in K003523, the Pinnacle system was expanded to include 36mm liners. The comparison chart of the 28mm and 36mm Pinnacle liners (K003523, Exhibit 4) indicates the 28mm and 36mm liners have identical diametrical clearances (4080gm). However, the sponsor has indicated in the subject submission that the 36mm liners have a clearance of 80-120gim. On 7/12/05 the sponsor was contacted by telephone to clarify the diametrical clearance of the 36mm system. The sponsor discovered the chart in Exhibit 4 of the predicate device is incorrect. According to the engineering drawings of K003523 the Pinnacle 36mm system has a diametrical clearance of 80-120pm. After this information was realized a search of the Medical Device Reporting Program (MDRs) for adverse events associated with the Pinnacle 36mm liners was completed. For the Pinnacle 36mm liners only 5 adverse events were reported. Three of these adverse events were failure for the liner and shell to line up appropriately, one adverse event was a patient revised due to pain and one adverse event gave no details. Over the same period of time, the comparable Sulzer metal-on-metal system had approximately 25 adverse events reported, while Zinimer had 3 reports regarding the 28mm acetabular insert and 3 reports regarding theft Cobalt Chrome femoral head. Therefore, during the same time period the 36mm Pinnacle system had a reasonable number of adverse events reported. Another example of various changes made to metal-on-metal systems without the support of clinical data is the Biomet M2aTM System. The Biomet M2aTM 28mm Acetabular System (K993438) had clinical data to support its safety and effectiveness when it was originally cleared. The system was expanded to include 32mm liners (K002379) without clinical data. Both sizes were composed of CoCrMo per ASTM F 1537, with the same tolerance bands and clearance between the modular heads and liners. In K0l11110, the M2a TMSystem was expanded to include 38mm components. The 38mm acetabular cup and modular heads are composed of CoCrMo per ASTM F75. The wear test for the 38mm components tested minimum and maximum diametrical clearance (55-167 gin) to ensure the worst case was evaluated. The sponsor states clearances and sphericities were slightly different than the 32mm components, but the clearances were not K040627 Page 29 of 31
clearly identified in the predicate device, so it is difficult to make a direct comparison. Clinical data was not provided for the change in material, diameter or clearance because the reviewer believed the changes could be addressed through mechanical testing. The only testing completed was wear testing for 5.5 million cycles. Biomet's next submission for the M2a Magnum System (K042037) increased diameter from 38mm to 4Omm-6Omm. These components are also composed of ASTM F75. Wear testing was completed and a range of clearances from 106-494 pim was evaluated. Since larger diameters have lower wear rates no concerns were found with increasing diameter or altering diametrical clearances. In the subject submission, the sponsor has completed (b) (4) (b) (4) , however, the largest size
On 7/21/05 an "Engineering Rounds" discussion was held to discuss changes in metal-on-metal hip systems that may or may not require new clinical data. We discussed this file and the Wright Medical CONSERVE Total Femoral Head (KO5 1348, under review). Based on the changes that have previously been allowed with mechanical testing according to the Biomnet description above, the proposed DePuy changes are comparable. The sponsor addressed our final concern regardin (b) (4) (b) (4) Therefore, the sponsor has adequately addressed our concerns regarding the changes in diameter, clearance and material from their own previously cleared Pinnacle System, which was supported by clinical data. The intended use, material, and design features of the DePuy ASR~m Modular Acetabular Cup System are Substantially Equivalent (SE) to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Line (K(002883, K003523) and the Biomet M2aTM System (K993438, K(002379, K003363, KOI011I10, K(042037).
1. Contact History/Requests for More Information:

5/14/04 - Spoke with Natalie Heck to discuss design and to confirm that this is a new system. 6/3/04 - Sponsor was sent an Al letter requesting more information on this systemn. 7/2/04 - Sponsor requested additional time for response through DMC 7/29/04 - Sponsor requested additional time for response through DMC 11/3 0/04 - Natalie Heck left a message, they are getting ready to submit response and have some questions - They have done more testing on resurfacing system - Asked if there were any particular concerns with instructions for use, none that I recall Received document off of hold Joint team recommends clinical data - Mark Melkerson, DGRND Deputy Director, and Ted Stevens, REDB3 Chief, recommend clinical data at 5 10(k) rounds 1/26/05 -File placed on hold, sponsor sent a deficiency letter requesting clinical data. 12/6/04 1/10/05 1/18/05
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Natalie Heck requested a face-to-face meeting to discuss our request for clinical data - Mike Courtney set up meetings: Pre-meeting Eni, 2/11 at I PM 020H, Sponsor meeting Thurs, 2/17 at 3PM 020H - Natalie Heck called and canceled 2/17 meeting 2/8/05 - Mike Courtney rescheduled for 3/3 at 2:30 PM - Sponsor cannot make time, Mike Courtney will attempt to reschedule again 2/10/05 - Sponsor reinstated 2/17 meeting from 3-4PM 2/11/05 - Left Natalie Heck a message asking if there is anything not in the letter that they would like to discuss during pre-meeting 2/4/05
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K040627 Page 30 of 31
Lit
2/16/05 - Received agenda for meeting and passed out to attendees 2/17/05 - Industry meeting, please see meeting minutes 3/1/05 - Natalie Heck requested one week extension - Referred her to Guidance Document that 30 Day timeftame is not strictly enforced, but she should request additional time, as soon as they decide course of action 3/4/05 - Natalie Heck called, they are going to pursue the 5 10(k) without clinical data -The sponsor will submit a supplement to the existing 5 10(k) -The sponsor will request a 90 day extension through DMC 3/7/05 - Received email copy of letter that the sponsor is sending to DMC requesting 90 Day Extension 3/16/05 - Mike Courtney wrote meeting minutes, I agree with them 5/17/05 - Natalie Heck called to say they would like to include an overview document and then address each question specifically, I told her that should be fine assuming each question is directly addressed - The sponsor anticipates responding by 5/24 5/25/05 7/12/05 Received Supplement 2 - Sponsor's response for predicate 3 6mm lists wrong clearances, predicate says identical clearances (K003523) - Called sponsor, the predicate chart is incorrect predicate clearances were changed - Metal-on-Metals Hips is a good topic for Engineering Rounds, scheduled for Wed., 7/20 7/20/05 - Took document to Joint Team to discuss that many predicates have actually changed diametrical clearances - Engineering Rounds - see minutes, don't need clinical data for changes, but we are concerned the largest components about (b) (4) - Left Natalie Heck a message that we want to know more about (b) (4) 7/22/05 - Called Natalie Heck to discuss large diameter heads and asked them to provide a rationale for (b) only completing (4) - The sponsor will consider (b) (4) - As for predicate 36mm Pinnacle (1K003523), they will submit an add to file to explain that predicate comparison table was inaccurate with Rebecca Lennard, Project 7/29/05 - Natalie Heck called to discuss (b) (4) Engineer - S1, Q5 response includes equation and estimated range for all sizes (b) (4) of the larger - I asked sponsor to see the actual calculations for the estimations of size components and asked how clearance play a role since the results indicate a larger clearance has (b) (4) - Natalie Heck left me a message that they would be willing to test larger sizes, but since that will (b) (4) take time, (b) (4) , please - I left the sponsor a message saying it is fine if they want to fax something to me 8/1/05 - Natalie Heck emailed meto say shechas not been able to fax me the document, she has Fed Exed a hard copy and emailed me an electronic version 8/2/05 - Received hard copy of Amendment 1
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(Date) eth L. Frank, M.S. Eli Devices Branch Orthopedic Division of General, Restorative and Neurological Devices
K(040627 Page 31 of 31
K040627 - Supplement 1: Original Deficiencies (with sponsor responses):

1.The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), white your predicate PinnacleTM Metal-on-Metal Acetabular Cup l (K003523 & K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM F-1537). (b) (4) (b) (4) . Report RDRO45/03 summarizes the (b) (4) (b) (4)
The sponsor concludes from the testing performed that there is no increase in safety concerns based upon or the ASR Uni head and cup bearing couple. The sponsor the changefrom (b) (4) has included several supporting references. Although the Wright Medical TRANSCEND Articulation System (K02 1349) is composed of Cast Co-CrMo alloy (ASTM F-75), this system had its own clearances and tolerances, which were proven to be safe and effective through their own clinical data. Your diametrical clearances and tolerances have not been identified in your submission. (b) (4) (b) (4)
The predicate Pinnacle metal on metal system had clearances ranging from (b) (4) . In support of the (b) (4) diametrical clearances defined, PDT 117/04, , the results are being used to support the report was performed using (b) (4) articulation of the large diameter unipolarfemoral heads and ASP acetabular cups that are part of the subject DePuy ASPRModular Acetabular Cup System 510(k) submission. DePuy believes that (b) (4) K040627/Sl
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Deficiency Responses Pg. 1
(b) (4)
All of these design differences can significantly influence the clinical outcomes for metal-on-metal hip arthroplasty devices. These changes present safety concerns that we feel cannot be addressed by preclinical testing and must be addressed by clinical data to support a determination of substantial equivalence of your 510(k). If the clinical data are collected in the US, the clinical data would need to be collected as part of a K040627/S I
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FDA-approved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design. The sponsor has not adequately addressed our concerns regarding the (b) (4) (b) (4) The sponsor will be asked to provide clinical data. 2. (b) The test reports submitted in Exhibit 4 refer to a (4) (b) (4) clarify which components of this system are identical to the components ). Please in the resurfacing IDE study and which are unique to this submission. (b) (4)
(b) (4)
on the worst-case scenario for the components in this Please complete approriate (b) (4) (b . Please submission or provide an ) justify your choice for the worst case femoral headl/acetabular cup construct (e.g. most likely the 63ram (4) head and cup). (b) (4)
K040627/S1 - Deficiency Responses Pg. 3
(b) (4)
3.
The submission states, "The modularity of using taper sleeve adapters in two taper options allow for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems." The size of the femoral head can affect the fatigue strength of the femoral (b stem in vivo. ) (4 ) ( b It is not the size of the femoral head) that affects the fatigue strength of the femoral stem, but rather the ( femoral head offset. Typical stem fatigue testing is performed with the worst-case offset, (b) (4) 4 (b) (4) )
4.
The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The taper sleeve adapter results in a somewhat hollow head design which may be susceptible to additional failure modes (i.e. fatigue fracture involving the cylindrical shaft in which the Sleeve Adapter fits) that a solid head would , to assess the strength of the cylindrical sleeve adapter shaft, is not encounter. We believe (b) (4) necessary to establish the safety and effectiveness of the device. Please provide an (b) (4)
(b) (4) Please see test report RDR063/04(b) (4) (b) (4)
5.
. In addition to The test reports included in Exhibit 4 address (b) (4) (b) (b) (4) have been known to cause component (b) (4) (4) is an important . Therefore, we believe the (b) (4) parameter in assessing the safety and effectiveness of a metal-on-metal hip system. Please provide both before and after the (b) (4) devices undergo (b) (4) (b) (4)
K040627/S1 - Deficiency Responses
Pg. 4
(b) (4)
The sponsor will be sent a letter requesting additional information with the following Deficiencies:
1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), with diametrical clearances of(b) (4) microns and sizes ranging from 39Metal-on-Metal Acetabular Cup (K003523, K002883) is composed of 63mm. Your predicate Pinnacle and diameters F-1537), with diametrical clearances between (b) (4) Wrought Co-Cr-Mo alloy (ASTM (b) 36mm. of 28 or (4) d (b) (4)
M T
a.
In Supplement 1, you referenced a previously submitted (b) (4) (b) (4)
b.
The diametrical clearances and tolerances provided in Supplement 1 range from (b) (4) (b) (4)
microns with a
c. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System has (b) (4) (b) (4)
K040627/S I - Deficiency Responses Pg. 5
we believe Based on our concerns regarding the changes in (b) (4) clinical data are necessary to support a new metal-onmetal system. If the clinical data are collected in the US, the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design. 2. and these results are Several of the provided test reports were performed using (b) (4) being used to support the articulation of the large diameter unipolar femoral heads and ASR acetabular cups in the subject submission. (b) (4) (b) (4) systems are evaluated as an entire assembly. Differences between the (b) (4) (b) (4) will affect the loading of the system, as well as wear patterns. We do not believe that can be appropriately substituted as preclinical testing for a total hip preclinical testing of a (b) (4) system. Therefore the following reports submitted in Supplement 1 are not considered to be applicable to this submission and the original deficiencies referencing these reports remain: * RDR 151/03 - (b) (4) (b) (4) RDR 117/04 -(b) (4) (b) (4) * (b) (4) (b) (4) *In addition, please recognize that the (b) (4) (b) (4) 3. used in this test report is . (b) (4)
data on the In response to Question 5, you have submitted (b) (4) resurfacing components of this system. As described above, we do not believe preclinical testing of (b) (4) (b) (4) provide comparable results, due to differences in in vivo loading conditions. Therefore, the original deficiency remains and both rotational and flexion/extension frictional torque data on the total hip system is requested. In addition, the provided lever-out testing for the acetabular cup does not address our (b) (4) concerns regarding rotati
The proposed acetabular component is a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating with the addition of DuoFix hydroxyapatite (HA) coating on the outer surface. Your previously cleared Pinnacle metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo superfinished metal liner that assembles into a porous coated, titanium alloy metal shell. We have concerns (b) (4) 4. (b) (4)
a.
b.
K040627/S 1 - Deficiency Responses Pg. 6
K040627 - Supplement 2:
Supplement 1 Deficiencies (with sponsor responses):

1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), with diametrical clearances of (b) (4) microns and sizes ranging from 39-63mm. Your predicate Pinnacle Metal-on-Metal Acetabular Cup (K003523, K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM F-1537), with diametrical clearances (b) (4) (b) microns and diameters of 28 or 36mm. The b (4) each testing: a. In Supplement 1, you referenced a previously submitted (b) (4) (b) (4) he
ASTM F75 requires that the carbon content of the cobalt chromium molybdenum (CoCrMo) casting alloy material be within the range of 0-.35%. The internal raw materialspecification for the subject ASRTM unifemoral head and cup specifies a carbon content within the range(b) (4) (b) (4) A copy of the internal raw material specification IRM 103-21-001 is provided in the rationale and technical overview. Adherence to this internal specification guarantees the device of the range required by the ASTM will have a carbon content within the (b) (4) of ASTM F1537 (Alloy 2 - High Carbon), specification. This range also fits the specifications which specifies a range of 0.15-0.35%. As described in the rationale and technical overview, the material combination (wrought or cast) is insignificant providing the conditions of elastohydrodynamic lubrication have been achieved through the design parametersof surface finish, form, diametricalclearance and the use of large diameter heads. Please refer to RDR 143/02 (Exhibit 4, Index item 3 "Hip Simulator,"K040627). This report details the work done to compare the wear performance of the wrought and cast material combinations using the previously cleared 36mm DePuy Pinnacle Metal on Metal Acetabular Cup design (K003523). The internal raw material specification for the wrought The carbon content of CoCrMo alloy requires a carbon content in the range of(b) (4) to a tighter tolerance than that of the wrought material thus the cast CoCrMo alloy is specified (b) specification. The results ensuring adherence consistently in the (4) is not a statistical difference between the wrought and cast high carbon demonstrate that there material combinations. Based on the carbon content requirements and testing performed, the sponsor believes that there is no increase in safety concerns based upon the change from wrought CoCrMo to cast CoCrMo for the ASR uni head and cup bearing couple. b. The diametrical clearances and tolerances provided in Supplement 1 range from (b) (4) (b) (4)
Pg. 1
(b) (4)
The sponsor notes that the stated predicate Pinnacle Metal-on-Metal Acetabular Cup system clearance range in the deficiency letter requires correction. The minimum and maximum clearances (microns) for the cleared metal-on-metal systems and the ASP modular system are (b) summarized in the table below. (4) (b) (4) memo. (b) (4)
(b) (4)
performed, the sponsor does not believe there is Based on the bearing design and the (b) (4) an increase in safety concerns based upon the increase in diametricalclearance. c. The proposed DePuy ASR Unit Femoral Head and Acetabualar Cup System has diameters ranging (b) (4)
Based on our concerns (b) (4) believe clinical data are necessary to support a new metal-onmetal system. If the clinical data are collected in the US, the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design
K040627/S2
Cd.
(b) (4)
The sponsor concludes from the analyses performed that there is no increase in safety concerns based upon the larger head diameters of the subject device as compared to the predicate device. and these Several of the provided test reports were performed using (b) (4) results are being used to support the articulation of the large diameter unipolar femoral heads and ASR acetabular cups in the subject submission. In Supplement 1 in response to question 2b, you state that (b) (4) (b) (4) While the hip systems are evaluated as an entire assembly. Differences articulating surfaces may be identical, head will affect the loading of the system, between the (b) (4) can be as well as wear patterns. We do not believe that preclinical testing of a (b) (4) appropriately substituted as preclinical testing for a total hip system. Therefore the following reports submitted in Supplement 1 are not considered to be applicable to this submission and the original deficiencies referencing these reports remain: 2. * RDR 15 1/03 (b) (4) * (b) (4) * (b) (4) *In addition, please recognize that the (b) (4) used in this test report is currently under ( . b By the nature of their design, hip joint replacement)devices transmit load through the bearingsurface, ( specifically the joint contact area. This is no different whether the femoral component takes the form (b) (4) In laboratorytesting simulation, 4 (b) ) (4) (b) (4) (b) (4)
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(b) (4)
(b) (4)
fi~ K040627/S2
-
(b) (4)
(b) (4)
3.
data on In response to Question 5, you have submitted (b) (4) of this system. As described above, we do not believe preclinical testing the (b) (4) provide comparable results, due to differences in in vivo of (b) (4) Therefore, the original deficiency (b) (4) loading conditions. (b) In addition, the provided (4) (b) (4) for the acetabular cup does not address our concerns regarding (b) (4) (b) (4) . versus the total Please see the response above (Question 2) regarding testing the (b) (4) was performed and a copy of the complete hip system. (b) (4) test report is provided in Exhibit!. Please see belowfor a summary of the testing.
(b) (4)
,SD
(b) (4)
4.
The proposed acetabular component is a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with PorocoatR porous coating with the addition of DuoFix hydroxyapatite (HA) coating on the outer surface. Your previously cleared Pinnacle metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo superfinished metal liner that assembles into a porous coated, titanium alloy metal (b) (4)
The DePuy ASRTM Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolarfemoralhead, and a taper sleeve adapter. The acetabular consists of a cobalt-chromium molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating. The outer porous coated surface of the cup has the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabularcups. The uni-femoral head is manufacturedfrom cobalt-chromium molybdenum (CoCrMo) alloy. The unifemoral heads have an internal taper mates with a taper sleeve adapter. The femoral heads articulate with the corresponding one-piece metal acetabularcups. The sponsor is changingfrom a liner and shell to a monoblock acetabularshell. The taper sleeve adapters are manufactured from cobalt-chromium molybdenum (Co CrMo) alloy. The DePuy PinnacleTm Metal-On-Metal (MOM) Acetabular Cup System is comprised of a metal acetabularshell, a metal acetabularcup insert, and modular metal femoral heads. The outer titanium aluminum vanadium ri-A1-4V) alloy acetabularcup is a hemispherical stepped and porous-coated shell with three dome screw holes, an apical hole used for visualization, and a peripheralfemale taper. The PorocoatD porous coating on the shell is commercially pure titanium. The superfinished metal liner is manufacturedlfrom cobalt-chromium molybdenum (CoCrMo) alloy. The metal insert mechanically locks with the metal shell via ataper junction. The modular heads are superfinished cobalt-chromium molybdenum (CoCrMo) alloy metal femoral heads. The metal femoral heads M-specification Articul/eze cobalt-chromium molybdenum (CoCrMo) alloy femoral heads with a 12/114 (A4rticul/eze) internal taper, and 5ROMM-Specification cobalt-chromium molybdenum (Co CrMo) alloy femoral heads with a 11/13 internal taper. K040627/S2 Deficiency Responses Pg. 6
As there are no separate shell/liner components to the ASR system, the requested comparison of the shell/liner assembly/disassembly forces and the shell/liner locking mechanism is not applicable. b. Preclinical and clinical data addressing concerns associated with wear and fixation due to the presence of HA coating or HA particulates and debris. Given the crystallinenature of the HA coatingand the strength of attachmentto the porous surface, the sponsor does notfeel there is a well-developed mechanism of particulatereleasefrom tissue or synovial fluid to subsequently migrateinto the the shell OD into the periarticular articularsurface. Thesponsorisnotawareofthisphenomenonoccurringintheclinicalsetting for HA coated metal-on-metal couples or HA coated metal-on-polyethylene couples. In the situation where an HA particlewould potentially be releasedfrom the acetabularshell and migrate into the articularregion, it would likely be very small in order to advance into the metalon-metal articularspace (less than 80-190 microns,for ASR articularsurfaces). The potential exists for the smallerparticleto pass through the articularregion, neither imbedding nor scratchingthe articularsurface. Alternatively, if the particlewere larger than the clearancebetween the articularsurfaces maintainedby thefluidfilm lubrication regime and became trapped within the articularsurfaces under the circumstances ofmicroseparation,the sponsor believes that severalthings would occur: * The very hardsurfaces of the CoCrMo alloy would crush the weaker and brittleHA particlecreating much smallersub-micron size particlesallowing them tofloatfreely out of the surface and become resorbedby the bodyfluids.
l If a largerHA particle were to scratch the articularsurface, the sponsor believes it would be fractured and washedfree of the articularsurfaces and the scratch would eventually repolish as metal-on-metal heads areknown to do. From the known clinicalexperience andlaboratory testing the sponsordoes not believe that these particles would cause degradationto the surface of the two hard, metal surfaces. HA coatings have previously been allowed on metal-on-metal systems. The sponsor has acknowledged the concerns associatedwith an HA coating on a hard-on-hard articulation,this is acceptable.

Pg. 7
Frank, Elizabeth L
From: ,nt: Peck, Jonathan H Wednesday, July 20, 2005 4:42 PM Frank, Elizabeth L; Melkerson, Mark N.; Stiegman, Glenn A; Horbowyj, Roxolana; Gantenberg, Julie *; Allen, Peter; Demian, Hany; Holden, John P; Hanafi, Nada 0; Rossi, Jeffrey; Janda, Michel D; Marjenin, Timothy A* Engineering Rounds Summary
Subject:
for First of all, thank you to Beth for her extensive preparation that led to a very productive discussion. And thank you all coming. Since this was sort of a policy setting meeting, I wanted to try to document just a little bit of what we talked about/agreed upon at the meeting. Please let me know if you think any of this needs to be changed. We discussed both of Beth's files:
(b) (4)
1.
2.
The second file involved several changes. The company is also proposing a material change from Cast CoCr (b They also propose larger head sizes to Wrought CoCr ( ) side by side wear testing and frictional torque which result in changes in clearance. The company provided (4 data. Again, the general consensus seemed to be that given the amount and compelling nature of preclinical information supplied, that these changes would be acceptable to cleared.
)
(b) (5)
,nathan Peck
xchanical Engineer FDA/CDRH/ODE/DGRND/Orthopedic Devices Branch 9200 Corporate Boulevard, HFZ-410
Memorandum of Meeting Minutes S nsor: De u" ASR Modular Hip Device Name: 2/17/05 Meetin Date: Metin Tme and Location: 9200Corporate Blvd. 3:00 P.M. 1040627 A lication Number (if a licable): FDA Attendees: Beth Frank, Lead VReviewer, Attendees: Steve Peoples, V.P. Sponsor Mark Melkerson, Dep. Dir./DGRND; John Clin/Reg Affairs, Depuy; Robert O'Holla, roodeSr Hodn cigB..OD;Jh V.P. Reg Affairs, J&J; Natalie Heck, Mgr. Reviewer/ORDB; Michael Courtney, Projec Reg. Afft, Depuy; Marlene Tandy, Sr. Mgr./ORDB Counsel, J&J; Rebecca Lennard, Hip Smith, Dir. Materials R&D, Depuy; Todd iouotesosrrgrigorrqe Research, Depu and provide clarificatintthspsoreadgourqet P3urpose of Meeting: To discuss for additional information dated January 26, 2005 for K040627 Sulement 1. (mtalon mtal)is lass III Pre-amendments device. May in the future call for * MO, *
(b) (4) (b) (4)
Points of Concurrence * More prudent to seek smaller changes rather than several major changes at one time. Burden is on the company to rationalize multiple changes at one time. * Why bad designs are bad and good designs good is not clearly understood. * FDA cannot extrapolate fluid film thickness tovaitearrclrnes Unresolved issues: * What is good/bad design in relation to clearances? * How to address the window compared to predicates? * Are loading patterns the same for same diameters with different angulations? * Needs to address HA w/hard on hard articulation outer shell, * What changes have taken place after initial design such as clearances, diameter, materials, geometry, etc? * Material change does not just depend on carbon content, processing and manufacturing also effect final product - therefore rely on clinical data, not just predicates for material selection * There are no pre-clinical testing surrogates for clinical data allow for * What is comfort level for clearance values? Company feels more open clearances better hydro dynamic fluid film lubrication. * Do differences in clearances influence dislocation rate, impingement, or subluxation? * Are there predictive wear tests to show less wear with larger diameter heads? (b) (4) * simulator~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~(K
Ne(b) (4)
repaed y: Minues
Mchal Curtney
Concurrence Branch Chief
Attach sponsor's handouts or powerpoint presentation Z Attach list of attendees J~ Attach sponsor's minutes, if provided. NOTE: sponsor's minutes have not necessarily been reviewed for accuracy. Z
5sT
DePuy - FDA Meeting Agenda ASR Modular Head 510(k) K040627 February 17, 2005 ODE Headquarters Rockville, MD
DePuy Attendees: Stephen Peoples, VMD, MS W VP, Clinical and Regulatory Affairs DePuy Natalie Heck Manager, Regulatory Affairs, DePuy Rebecca Lennard Project Engineer, DePuy Todd Smith Director, Research, DePuy The purpose of the meeting is to discuss and gain clarification regarding several items discussed in the request for additional information dated January 26, 2005 for K040627. Hardcopy handouts summarizing the issues to be discussed and clarified relative to the deficiency letter will be presented at the start of the meeting and used as points of discussion during the meeting. General discussion topic:
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Robert O'Holla VP, Regulatory Affairs, Johnson & Johnson Marlene Tandy, M.D., J.D. Senior Counsel, Johnson & Johnson
ASR XL (submitted as Modular Acetabular System) K040627 in comparison to recently 510(k) cleared SE predicate devices
discussion of K040627 device
Technical discussion topics:

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ASTM F-75 carbon content Head / cup clearance dimensions

(b) (4)
HA coating
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Reviewer(s) - Name(s) 510(k)Numbe

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It is my recommendation that the subject 510(k) Notification:
ElRefused to accept. '4equires additional information (other than refuse to accept).

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-INOT substantially equivalent to marketed devices.
[-Other (e.g., exempt by regulation, not a device, duplicate, etc.)
Is this device subject to Section 522 Postmarket Surveillance? Is this device subject to the Tracking Regulation? Was clinical data necessary to support the review of this 510(k)" Is this a prescription device'? Was this 510(k) reviewed by a Third Party? Special 510(k)?
Abbreviated 510(k)? Please fill out form oi H Drive 5lOk/boilers EYES EYES YES KZYES E]YES EYES EYES NO NO " 'El NO [ NO 'U NO 1I NO , NO
Truthful and Accurate Statement El Requested
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R'A 510(k) summary OR -A 510(k) statement

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Animal Tissue Source
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YES
El NO
Material of Biological Origin
YES
NO
The submitter requests under 21 CFR 807.95 (doesn't apply for SBs): exceeding 90 days El No Confidentiality [] Confidentiality for 90 days /,4Continued Confidentiality Predicate Product Code \vith class: Additional Product Code(s) with panel (optional):
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"SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION

K040627 Reviewer: Elizabeth L Frank Division/Branch: DGRND/ORDB Device Name: DePuy ASRTM Modular Acetabular Cup System Product To Which Compared (510(K) Number If Known): K965156, K002883, K003523, K021349 YES NO 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Is Product A Device Is Device Subject To 510(k)? Same Indication Statement? Do Differences Alter The Effect Or Raise New Issues of Safety Or Effectiveness?
Descriptive Characteristics Precise Enough? New Types Of Safety Or Effectiveness Questions? Accepted Scientific Methods Exist? Performance Data Available? Data Demonstrate Equivalence? X X X X X X X X If NO Stop IfNO Stop
If YES - Go To 5 If YES = Stop NE

If YES
=
Go To 7
If YES - Go To 8
If NO = Go To 10
If YES Stop SE
If YES
=
Stop NE
If NO - Stop NE If NO - Request Data Final Decision:
Note: In addition to completing the form on the LAN, "yes" responses to questions 4, 6, 8, and 11, and every "no" response requires an explanation.
K040627
1. Intended Use: m The DePuy ASR T Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. 2. Device Description: The acetabular component is designed as a cast CoCrMo alloy (ASTM F-75) one-piece cup with Porocoat porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shell has a highly polished, superfinished internal bearing surface, and is available with outer diameter sizes 44-70 mm in 2mm increments with inner diameters ranging from 39-63mm. There is no separate liner component to this system, as it is a one-piece acetabular shell used with a unipolar femoral head and a taper sleeve adapter. The uni femoral head is manufactured from cast high carbon CoCrMo alloy (ASTM F-75) and is available in a range of diameters from 39-63mm in 2mm increments. All of the uni femoral heads have an internal taper which mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13 tapers corresponding to the external tapers on DePuy femoral stems. The femoral heads have a highly polished, superfinished exterior bearing surface, and articulate with corresponding one-piece metal acetabular cups. The sponsor states that the material, (currently under IDE outer diameter, clearances and surface finishes of the (b) (4) are identical to the subject unipolar femoral head. (b) (4) investigation, (b) (4) . (b) (4) The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity of using taper sleeve adapters in two taper options allows for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems. The ASR 12/14 taper sleeve adapters are manufactured from forged cobalt-chrome-molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters are manufactured from wrought CoCrMo alloy and were previously cleared in the Ultima Unipolar Head and Sleeve (K965 156) and are offered in neck length options of+0, +6, and +12. EXPLANATIONS TO "YES" AND "NO" ANSWERS TO QUESTIONS ON PAGE 1 AS NEEDED 1. Explain why not a device: Explain why not subject to 510(k): 2. How does the new indication differ from the predicate device's indication: 3. Explain why there is or is not a new effect or safety or effectiveness issue: 4. Describe the new technological characteristics: 5. The subject total metal on metal hip system is composed of a different material, comes in much large sizes with larger diametrical clearances than the sponsor's own previously cleared predicate device. 6. Explain how new characteristics could or could not affect safety or effectiveness: (b) (4) ay affect the triobiological properties of the system, which could lead to seizing and loosening. It is unknown what clinical effect these changes will have. Explain how descriptive characteristics are not precise enough: Explain new types of safety or effectiveness questions raised or why the questions are not new: The questions are not new, they are the same safety and effectiveness questions raised for any new metal on metal hip system. Explain why existing scientific methods can not be used: Explain what performance data is needed: The sponsor should provide clinical data to address the safety concerns raised by the subject changes to their own predicate device. Explain how the performance data demonstrates that the device is or is not substantially equivalent:
7. 8.
9. 10.
11.
K040627
Q12
INTERNAL ADMINISTRATIVE FORM:

YES 1. DIdh firm request expedited review? 2. Ddwe grant expedited review? 3Have yu verified that the Document is labeled Class III for GMP purposes? 4. Inot, has POS been notified? 5 Is th product a device? 6. Is th device exempt from 5 10(k) by regulation or policy? 7. Is the device subject to review by CDRH? 8. Are you aware that this device has been the subject of a previous NSE decision? 9. If yes, does this-new 510(k) address the NSE issue(s), (e.g., performance data)? -10. Are you aware of the submiitter being the subject of an integrity investigation? II. If, yes, consult the ODE Integrity Officer. 12. Has the ODE Integrity Officer given permission to proceed with the review? (Blue Book Memo #191-2 and Federal Register 90N0332, September 10, 199 1. NO X N/A
___
X X
N/A X x
___ ___ ___
x N/A X N/A N/A
_______
K(040627
To: From: Date: Device: Company:
Contact:
K040627.S1 Elizabeth Frank, Biomedical Engineer, M.S. FDA/CDRH/ODE/DGRND/Orthopedic Devices Branch (HFZ-4 10) January 24, 2005 DePuy ASRTM Modular Acetabular Cup System Product Code: 87 KWA (21 CFR 888.3330), Class III DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Warsaw, IN 46581-0988 Natalie Heck, Manager, Regulatory Affairs Phone: 574-372-7469, Fax: 574-371-4939, Email: nheckidpyus.in.com
Recommendation: The file will be placed on hold and the sponsor will be sent an Al letter with the deficiencies listed at the end of this memo asking for clinical data. Review: l. Administrative Requirements: The submission contains a 510(k) Summary, a Truthful and Accuracy Statement and Indications for Use page. Device Description: Acetabular Shell Component: The acetabular component is designed as a cast cobalt-chrome-molybdenum (CoCrMo) alloy (ASTM F-75) one-piece cup with Porocoat porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shell has a highly polished, superfinished internal bearing surface, and is available with outer diameter sizes 44-70 mm in 2mm increments with inner diameters ranging from 3963mmn.There is no separate liner component to this system, as it is a one-piece acetabular shell used with a unipolar femoral head and a taper sleeve adapter. The acetabular shell is identical to the (b) (4) (b) (4) The predicate DePuy Pinnacle system (K003523, K002883) is composed of wrought Co-Cr-Mo alloy (ASTM F-1537) and comes in sizes of 28 or 36mm. The shell component uses the same Porocoat process used for the predicate device (K002883 & ( K003523). The coating consists of b (b) (4) Table I includes a summary of the properties of the Porocoat porous ) coating: ( 4 Properties Porous Coating Table I: Porocoat (b) (4) )
2.
K040627 Pg. I of 17
(>7
hydroxyapatite (HA) coating. The outer surface of the cup has the addition of a (b) (4) on the CoCrMo Porocoat substrate are found in (b) (4) Characteristics of the HA coating (b) (4) The HA material conforms to ASTM Fl 185-88 for hydroxyapatite (Ca 5(P04) 0H) ceramic. 3 The sponsor must demonstrate that the HA coating on the porous coated ASR Acetabular Shell does not influence wear and device/bone fixation. They will be asked to provide data comparing range-ofmotions, shell-liner assembly/disassemblyforces, and the acetabular sheltlinsert locking mechanism to the predicate Pinnacle system (K003523, K002883), which only had a porous coating.. Femoral Component: The uni femoral head is manufactured from cast high carbon cobialt-chromium-molybdenumn (CoCrMo) alloy (ASTM F-75) and is available in a range of diameters from 39-63mmn in 2mm increments. All of the uni femoral heads have an internal taper which mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13 tapers corresponding to the external tapers on Deputy femoral stems. The femoral heads have a highly polished, superfinished exterior bearing surface, and articulate with corresponding one-piece metal acetabular cups. The sponsor states that the material, outer diameter, clearances and surface finishes ( ) are identical to the subject of the b unipolar femoral head. The predicate DePuy Pinnacle system (K003523, K002883) is composed of wrought Co-Cr-Mo alloy (ASTM F-1 537) and comes in sizes of 28 or) 36mm. ( 4 Diametrical Clearances: acetabular cups) are provided in Table The-diametric~al clearances for all femoral implants (femoral heads to ) . 2 below. The predicate DePuy Pinnacle system has diametrical clearances ranging from (b) (4) Table 2: DiametricalClearances (b) (4)
Taper Sleeve Adapters. The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity of using taper sleeve adapters in two taper options allows for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems. The ASR 12/14 taper sleeve adapters are manufactured from forged cobalt-chrome-molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The I11/ 13 taper sleeve adapters are manufactured from wrought CoCrMo alloy and were previously cleared in the LUltima Unipolar Head and Sleeve (K965 156) and are offered in neck length options of +0, +6, and 1-12.
K040627 Pg. 2 of 17
A list of all sizes of the DePuy ASRTM Modular Acetabular System is included in Exhibit 1 with a list of compatible components. Device photographs are included on page 13 and engineering drawings are provided in Exhibit 2. The taper sleeve adapter drawings are included on page 13 of Supplement 1. Tables 3 and 4 summarize the similarities and differences between the subject and predicate devices. The ASR Uni Femoral Head and Acetabular Cup System is considered a new metal on metal system that will require clinical data. Deficiency #1 discusses the design differences between the subject device and (b) (4) the predicate DePuy Pinnacle system. The subject device and the ( , have identical articulating surfaces. b ) Intended Use: ( The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures 4 for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid ) arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The indications for use statement is the same as the Pinnacle Metal-On-Metal Acetabular Cup Liner (K003523), except it has been revised from the acetabular component in total hip replacement to the entire total hip replacement. 4. Sterilization: Radiation Type: Gamma Radiation Source: (b) (4) Minimum Dosage: (b) (4) Sterility Assurance Level: (b) (4) Sterility Validation Method:
3.
5.
(b ) ( (b (4 b ) ) ) (4 ( Labeling: 4 The instructions for use and ) draft labels are provided in Exhibit 3. The package labels contain the ) insert for the DePuy ASR Modular Acetabular Cup System appropriate information. The package (device description, indications, contraindications, potential adverse contains all appropriate information events, warnings and precautions, cleaning and sterilization information).
K040627 Pg. 3 of 17
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K040627 Pg. 6of 17
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Sponsor's Information in support of SE: DePuy Pinnacle Metal-on-Metal Acetabular Cup Liner (K003523, K002883) Wright Medical Metal TRANSCEND Articulation System (K02 1349) DePuy Ultima Unipolar Head and Adapter Sleeves (K965 156) Review of other 51O(k)s/IDEs: Wright Medical Metal TRANSCENDK Articulation System (K004043/S00lI) Corin USA Cormet Large Diameter Metal on Metal Hip System IDE (G030265) Bionmet M2a TMMagnum Hip System (K(042037) BiometMN2alTM 38mmn(KOlI11 1O)
8.
K040627 Pg. 9 of 17
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9.
Summary: The sponsor has not demonstrated that their device is SE to the Pinnacle Metal on Metal System. Clinical data is necessary for this new metal on metal system. The subject device has identical articulating surfaces (b) (4) The sponsor has to the and to provide been asked to complete bench top testing on the subject device, (b) (4) clinical data in support of the new design of the total metal on metal system. The sponsor will be sent an Al letter with the deficiencies below. Contact History/Requests for More Information: 5114/04 - Spoke with Natalie Heck to discuss design and to confirm that this is a new system. 6/3/04 - Sponsor was sent an Al letter requesting more information on this system. 7/2/04 - Sponsor requested additional time for response through DMC 7/29/04 - Sponsor requested additional time for response through DMC 11/30/04 - Natalie Heck left a message, they are getting ready to submit response and have some questions - They have done more testing on (b) (4) - Asked if there were any particular concerns with instructions for use, none that I recall 12/6/04 - Received document off of hold (90 days up) 1/10/05 - Joint team recommends clinical data 1/18/05 - Mark Melkerson, DGRND Deputy Director, and Ted Stevens, REDB Chiefrecommend clinical data at 5 10(k) rounds
10.
E~~ethL~r )A41 nk MS.(Date) Eliz Orthopedic Devices Branch Division of General, Restorative and Neurological Devices
Original Deficiencies (with sponsor responses): I.The proposed DePuy ASR Unit Eemoral Head and Acetabular Cup System is composed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), while your predicate Pinnacle TM Metal-on-Metal Acetabular Cup (K003523 & K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM E-1537). The change in material alters the articulating surfaces of your system creating new safety concerns. Report RDR045103 (b) (4) (b ) (4 )
K040627
Pg. 10 of 17
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Although the Wright Medical TRANSCEND Articulation System (K021349) is composed of Cast Co-CrMo alloy (ASTM F-75), this system had its own clearances and tolerances, which were proven to be safe and effective through their own clinical data. Your diametrical clearances and tolerances have not been identified in your submission. pe " kix (b) (4) b ip dtri u*m
The predicate Pinnacle metal on metal system had clearances rangingfrom 39-63mm. This is a large increase in clearance, which has not previously been allowed without supporting clinical data. In (b) support of the diametrical clearances defined, RDT 117/04, (4) (b) (4)
K040627 Pg. 11 of 17
(b) (4)
In addition, you have proposed 39-63mm inner diameters for your acetabular cups with matching femoral Your Pinnacle predicate only exists in 28 and 36 mm sizes and the Wright head diameters. TRANSCEND System is 38-54mm. It is unknown what effect increasing the diameter to 62mm will have on the clinical use of the system. While we have allowed several small increases in diameters with appropriate bench top testing, we are unsure how large is actually safe for clinical use. (b) (4)
The sponsor concludes that there is no increase in safety concerns based upon the largerhead diameters of the subject device. The sponsor has included several abstracts in support of this argument. All of these design differences can significantly influence the clinical outcomes for metal-on-metal hip arthroplasty devices. These changes present safety concerns that we feel cannot be addressed by preclinical testing and must be addressed by clinical data to support a determination of substantial equivalence of your 510(k). If the clinical data are collected in the US, the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design. The sponsor has not adequately addressed our concerns regarding the change in material, size and diametricalclearance. Thesponsorwillbeaskedtoprovideclinicaldata. 2. (b) dy The test reports submitted in Exhibit 4 refer to a (4) (b) (4) clarify which components of this system are identical to the components ). Please and which are unique to this submission. in the(b) (4) (b) (4)
(b) (4)
K040627 Pg. 12 of 17
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Please complete approriate wear and corrosion testing on the worst-case scenario for the components in this submission or provide an engineering rationale explaining why the current test reports are adequate. Please justify your choice for the worst case femoral head/acetabular cup construct (e.g. most likely the 63mm head and cup). (b) (4)
3.
The submission states, "The modularity of using taper sleeve adapters in two taper options allow for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems." The size of the femoral head can affect the fatigue strength of the femoral stem in vivo. Therefore, we (b) (4) (b) (4)
It is not the (b) (4) (b) (4)
Typical stem
(b ) (4 )
(b) (4)
K040627 Pg. 13 of 17
4.
The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The taper sleeve adapter results in a somewhat hollow head design which may be susceptible to additional failure modes (i.e. fatigue fracture involving the cylindrical shaft in which the Sleeve Adapter fits) that a solid head would not to assess the strength of the cylindrical sleeve adapter shaft, is encounter. We believe (b) (4) necessary to establish the safety and effectiveness of the device. Please provide an engineering justification with the worst case or a complete test report containing fatigue testing data per ISO 7206-6 (b) (4) under worst case physiological loading conditions. Please couple the heads with a stem you head design plan to make available for this study. Please justify your choice for the worst case head design (most likely the 63mm head). Please see test report RDR063/04 " (b) (4) . (b) (4)
5.
(b) (4) The test reports included in Exhibit 4 address wear concerns, frictional effects have been known to cause component seizing and loosening in metal-onmetal hip systems. Therefore, we believe the friction between the bearing surfaces is an important parameter in assessing the safety and effectiveness of a metal-on-metal hip system. Please provide interfacial, rotational and flexion/extension, frictional torque data on the system both before and after the devices undergo wear testing.
(b) (4)
References Title: The Otto Aufranc Award. Wear and lubrication of metal-on-metal hip implants. Author(s): Chan FW, Bobyn JD, Medley JB, Krygier JJ, Tanzer M. Volume: Clin Orthop. 1999 Dec. (369)10-24 The implication of polyethylene wear particles as the dominant cause of periprosthetic osteolysis has created a resurgence of interest in metal-on-metal implants for total hip arthroplasty because of their potential for improved wear performance. Twenty-two cobalt chromium molybdenum metal-on-metal implants were custom-manufactured and tested in a hip simulator. Accelerated wear occurred within the first million cycles followed by a marked K040627 Pg. 14 of 17
[c/P
decrease in wear rate to low steady-state values. The volumetric wear at 3 million cycles was very small, ranging from 0.15 to 2.56 mm' for all implants tested. Larger head-cup clearance and increased surface roughness were associated with increased wear. Independent effects on wear of material processing (wrought, cast) and carbon content were not identified. Implant wear decreased with increasing lambda ratio, a parameter used to relate lubricant film thickness to surface roughness, suggesting some degree of fluid film lubrication during testing. This study provided important insight into the design and engineering parameters that affect the wear behavior of metal-on-metal hip implants and indicated that high quality manufacturing can reproducibly lead to very low wear. As quoted in the text, "Certainly, with similar ranges in clearance and roughness values, no statistical difference between the high C wrought and high C cast implants was identified. Title: Analysis of Fluid Film Lubrication in Artificial flip Jiont Replacements with Surfaces of High Elastic Modulus Author(s): Z M din; D Dowson; J Fisher Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine Volume: 211 Page: 247-256 Abstract: Lubrication mechanisms and contact mechanics have been analyzed for total hip joint replacements made from hard hearing surfaces such as metal-on-metal and ceramnic-on-ceramic. A similar analysis for ultra-high molecular weight polyethylene (UHMWPE) against a hard bearing surface has also been carried out and used as a reference. The most important factor influencing the predicted lubricating film thickness has been found to be the radial clearance between the ball and the socket. Full fluid film lubrication may be achieved in these hard/hard bearings provided that the surface finish of the bearing surface and the radial clearance are chosen correctly and maintained. Furthermore, there is a close relation between the predicted contact half width and the predicted lubricating film thickness. Therefore, it is important to analyze the contact mechanics in artificial hip joint replacements. The effect of femoral head diameter upon lubrication and wear of metal-on-metal total hip Title: replacements Author(s): S L Smith; D Dowson; A ASJ Goldsmith Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine Volume: 215 Page: 161-170 Abstract: It has been found that a remarkable reduction in the wear of metal-on-metal hip joints can be achieved by simply increasing the diameter of the joint. A tribological evaluation of metal-on-metal joints of 16, 22.225, 28 and 36 nun diameter was conducted in 25 percent bovine serum using a hip joint simulator. The joints were subject to dynamic motion and loading cycles simulating walking for both lubrication and wear studies. For each size of joint in the lubrication study, an electrical resistivity technique was used to detect the extent of surface separation through a complete walking cycle. Wear of each size of joint was measured gravimetrically in wear tests of at least 2x 106 cycles duration. Joints of 16 and 22.225 mm diameter showed no surface separation in the lubrication study. This suggested that wear would be proportional to the sliding distance and hence joint size in this boundary lubrication regime. A 28mm diameter joint showed only limi~ted evidence of surface separation suggesting that these joints were operating in a mixed lubrication regime. A 36 nun diameter joint showed surface separation for considerable pants of each wvalking cycle and hence evidence of the formation of a protective lubrication film.
6 3 Wear testing of 16 and 22.225 nun diameter metal-on-metal joints gave mean wear rates of 4.85 and 6.30 mm l/10 cycles respectively. The ratio of these wear rates, 0.77, is approximately the same as the joint diameters ratio, 16/22.225 or 0.72, as expected from simple wear theory for dry or boundary lubrication conditions. No bedding-in was observed with these smaller diameter joints. For the 28 nun diameter joint, from 0 to 2x 106 cycles, the mean 6 6 `/l0 wear rate was 1.62 rm 3 6 cycles as the joints bedded-in. Following bedding in, from 2.0x1 0 to 4.7x10 cycles, the wear rate was 0.54 MM3/106 cycles. As reported previously by Goldsmith et at. in 2000, the mean steady state 6 3 wear rate of the 36 mm diameter joints was lower than those of all the other diameters at 0.07 mm '/10 cycles. For a range of joints of various diameters, subjected to identical test conditions, mean wear rates differed by almost two orders of magnitude. This study was demonstrated that the application of sound tribological principles to prosthetic design can reduce the wear of metal-on-metal joints, using currently available materials, to a negligible level.
K040627
Pg. 15 of 17
Supplement 1 Deficiencies: 1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon microns and sizes ranging from 39Co-Cr-Mo alloy (ASTM F-75), with diametrical clearances of(b) (4) 63mm. Your predicate Pinnacle Metal-on-Metal Acetabular Cup (K003523, K002883) is composed of microns and diameters Wrought Co-Cr-Mo alloy (ASTM F-1537), with diametrical clearances between (b) (4) of 28 or 36mm. The material, diametrical clearances and diameters of a total metal on metal hip system characterize the system, each supported with its own set of clinical data. In Supplement 1, you have attempted to justify each of these changes with preclinical testing:
M T
a.
(b) (4) In Supplement 1, you referenced a previously submitted (b) (4)
b.
The diametrical clearances and tolerances provided in Supplement 1 range from (b) (4) (b) (4)
with a
c.
The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System has diameters ranging from 39(b) (4)
Based on our concerns (b) (4) clinical data are necessary to support a new metal-onmetal system. If the clinical data are collected in the US, the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design. , and these results are Several of the provided test reports were performed using (b) (4) being used to support the articulation of the large diameter unipolar femoral heads and ASR acetabular cups in (b) (4) 2.
(b) (4) will affect the loading of the system, as well as wear patterns. We do not believe that can be appropriately substituted as preclinical testing for a total hip preclinical testing of a(b) (4) system. Therefore the following reports submitted in Supplement 1 are not considered to be applicable to this submission and the original deficiencies referencing these reports remain: K040627 Pg. 16 of 17
(b) (4)
used in this test report is (b) (4) *In addition, please recognize that the (b) (4) (b) (4) (b) (4) ue data on the 3. In response to Question 5, you have submitted (b) (4) of this system. As described above, we do not believe preclinical testing of (b) (4) (b) (4) , due to differences in in vivo loading conditions. Therefore, remains and (b) (4) the original deficiency for the acetabular cup does not address our system is requested. In addition, the provided (b) (4) . (b) (4) concerns regarding The proposed acetabular component is a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating with the addition of DuoFix bydroxyapatite (HA) coating on the outer surface. Your previously cleared Pinnacle metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo superfinished metal liner that assembles into a porous coated, titanium alloy metal shell. We have concerns that (b) (4) 4. a. (b) (4)
b.
K040627 Pg. 17 of 17
& HUMAN SERVICES DEPARTME~qT OF HEALTH
From:i~
Subject: To:
Reviewer(s)
Name(s)
[1; z,,[,t
L Fc
t_
510(k) Number
qo 6o_
that the subject 510(k) Notification: Record It is my recommendation The [] Refused to accept.
(other than refuse to accept).
,14equires additional information marketed devices. El is substantially equivalent to to marketed devices.
[]NOT substantially equivalent duplicate, etc.)
O]Other (e.g., exempt by regulation, not a device, Postmarket Surveillance? I~~~~~~~~~~~'~ Is this device subject to Section 522 Regulation? Is this device subject to the Tracking the review ofthis 10(k)? Was clinical data necessary to support Is this a prescription device? Party? Was this 510(k) reviewed by a Third Special 510(k)? out form on H Drive 510klboilers Abbreviated 510(k)? Please fill DYES DYES
*NO
~[ NO El NO , El NO f NO m NO 'SNO
IYES
EYES UYES ElYES BYES
El Requested'.Enclosed
Truthful and Accurate Statement 5
B~ 510(k) summary OR U A 510(k) statement
III devices
for class The required certification and summary
S~The indication for use form

algorithm on H drive 5l0k/Boilers)
Product Category (Please see Combination
Animal Tissue Source
YES
El NO Material of Biological Origin
E] YES
NC
CFR 807.95 (doesn't apply for SEs): The submitter requests under 21 Confidentiality exceeding 90 dt [E Confidentiality for 90 days '$ Continued El No Confidentiality panel (optional): Additional Product Code(s) with Product Code with class: Predicate
Final Review: (Division Director)

Revised:4/2/03
(Date)
510(k) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS

De, c
\ttrkct
woc tipcitcd tb, c I )t'Ice
I. c. Nc%I I)cscript. ic Initormaioo. Indication about New or Marketed Device Requested as Needed
ice Ilave Same atem entI
NO
ES
New Device Has S eIntended "Sbstially Equivalent" Use and May be SubNew
Do the Difikrences Alterr the Intended Therapeutic/DiagnostiCtc. EffEt l (in Deciding. MayConsider Impact on Safety and Etlectiveness)?**
Not StIhstVantiaI
YES
Euivalem Deternination
I1
NO
Device Has
Q~~~~~~~~f
NO
.
~~~~~~~New Intended Use
D)oes New Device Il:

cg I)esiuin. MIteriji
Same
Could the New
~t,~;~-
leclinoloicat hliara ristics. YES
'racttrlstics
'Al't
Safety or -
7
NO, 10 NO NO Are the Descriptive Characteristics Precise Enough
Etlketiveness?
NO
Raise New Iesot Satety or Effectiven, Questions?
YES
to Ensure Equivalence?
(
Qt
Do Acc Meth Assessi New th1e C0
NO
e
d Scientific Exist for NO Effects of aracteristics? S
Are Pertormance lata Available to Asses Equivalence?
YES
YE'S
I'crlbrmatce Required ata D
Data Available Are Perlornia To Ass Characteristics? ***
55
tPertbrniance Data Demonstrate Equivalence?
(H l
"Stubstantially Equivalent" Detematination
iNYESOYES
Perfornmiance Data Demonstrate Equivalence?

NO
ITo
To To
1arketed
infournation ilt tie relationship betwecn H j i(k) Mtbmiissiois compare new devices to marketed devices. FDA requests additional uiclear is and predicate" (pre -Amendmnents or reclassitied post-Anmenldments) devices required. isis normiallv based on descriptive information alone, but lirmied testing initbrm ation is sometimles inthe
* **
hIlis dcc
maybe ~Data
10(k). other 510(k)s, thc Center's classification tilts, or the literaturc.
QS3
SCREENING CHECKLIST FOR ALL PREMARKET NOTIFICATION [510(k)1 SUBMISSIONS 510(k) Number: 0 4 06 (V-7
The cover letter clearly identifies the type of 510(k) submission as (Check the
appropriate box): [I El Special 510(k) Abbreviated 510(k) Do Sections 1 and 2 Do Sections 1,3 and 4 Do Sections 1 and 4
Traditional 510(k) or no identification provided
Section 1: Required Elements for All Types of 510(k) submissions: Present or Adequate Cover letter, containing the elements listed on page 3-2 of the
Premarket Notification [510)] Manual.
Table of Contents.
Truthful and Accurate Statement.
Device's Trade Name, Device's Classification Name and
Establishment Registration Number.
Device Classification Regulation Number and Regulatory Status
(Class 1,Class II, Class III or Unclassified).
Proposed Labeling including the material listed on page 3-4 of the
Premarket Notification [510)] Manual.
Statement of Indications for Use that is on a separate page in the
premarket submission.
Substantial Equivalence Comparison, including comparisons of
the new device with the predicate.
5100c) Sunmary or 510(k) Statement.
Description of the device (or modification of the device) including
diagrams, engineering drawings, photographs or service manuals.
Identification of legall marketed predicate device. *
Compliance with performance standards. * [See Section 514 of
the Act and 21 CFR 807.87 d
Class III Certification and Summary. **
Financial Certification or Disclosure Statement for 510(k)
notifications with a clinical study. * [See 21 CFR 807.87 (i)]
/A
510(k) Kit Certification *** *
-
Missing or Inadequate
L_
May not be applicable for Special 510(k)s.

- Required for Class III devices, only.
- See pages 3-12 and 3-13 in the Premarket Notification [510)] Manual and the
Convenience Kits Interim Regulatory Guidance.
Section 2: Required Elements for a SPECIAL 510(k) submission:
Present
Inadequate
or Missing Name and 510(k) number of the submitter's own, unmodified redicate device. A description of the modified device and a comparison to the sponsor's predicate device. of and indications the the b statement that ritended use(s) are the same as the as described in its labeling modified device, indications submitrer's unmodified for the a intended uses nd ate tredic device. fundamental scientific technology of the submitter's predicate device. that the following includes A DesignControl Acivities Summary a. Identification of Risk Analysis method(s)used to assess ile and impact ofthe modification on the device athe its components, and h risknanalyis allee requirdifby rmethato as Aeiwe' state o t resultshe f the analysis. of due b. Rvieeriscoficmation Risk Analysis, an identificationplerfred bythe Based on the tand valimdication hacites were required verification and validation activities, including the methods or tests used and the acceptance criteria to be applied. c. A Declaration of Conformity with design controls that includes the following statemnents: A statement that, as required by the risk analysis, all verification and validation activities were performed by thc designated individual(s) and the results of the activities demonstrated that the predetermined acceptance criteria were individual responsible is statement signed by the met. This forhose particular activities. t A statement that the manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. This statement is signed by the individual responsible for those particular activities. Section 3: Required Elements for an ABBREVIATED 510(k)* submission: Present For a submission, which relies on a guidance document and/or special control(s), a summary report that describes how the guidance and/or special control(s) was used to address the risks associated with the particular device type. (If a manufacturer elects to use an alternate approach to address a particular risk, sufficient detail should be provided to justify that approach.) For a subimssion, which relies on a recognized standard, a declaration of conformity [For a listing of the required elements of a declaration of conformity, SEE Required Elements for a Declaration of Conformity to a Recognized Standard, which is posted with the 510k)boilers on the H drive.] Inadequate or Missing
For a submission, which relies on a recognized standard without a declaration of conformity, a statement that the manufacturer intends to conform to a recognized standard and that supporting data will be available before marketing the device. For a submission, which relies on a non-recognized standard that has been historically accepted by FDA, a statement that the manufacturer intends to conform to a recognized standard and that supporting data will be available before marketing the device. For a submission, which relies on a non-recognized standard that has not been historically accepted by FDA, a statement that the manufacturer intends to conform to a recognized standard and that supporting data will be available before marketing the device and any additional information requested by the reviewer in order
to determine substantial equivalence. Any additional information, which is not covered by the guidance document, special control, recognized standard and/or nonrecognized standard, in order to determine substantial
equivalence.
-
When completing the review of an abbreviated 510(k), please fin out an Abbreviated Standards Data Form (located on the H drive) and list all the guidance documents, special controls, recognized standards and/or non-recognized standards, which were noted by the sponsor.
Section 4: Additional Requirements for ABBREVIATED and TRADITIONAL 510(k) submissions (If Applicable): Present a) Biocompatibility data for all patient-contacting materials, OR certification of identical material/formulation: b) Sterilization and expiration dating information:
il ii) iii) iv'} vx sterilizition nrocess validition method of sterilization nrocess SAT, nnckaginQ snecifly nrogen free vil FTO residues
Inadequate or Missin_
vii) radiation dose

viii) Traditional Method or Non-Tradiional Method
_
c)
Software Documentation:
NA/
Items with checks in the 'Present orAdequate" column do not require e additional informationfrom the sponsor. Items with checks in the "Missing or Inadequate" inust be submitted before substantive review of the document. column Yes _ _ _ Reviewer:r Concurrence by Review Branch:
Passed Scre ' No
__
Date: /
The deficiencies identified above represent the issues that we believe need to be resolved before our review of your 510(k) submission can be successfully completed. In developing the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i) of the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of your device. We also considered the burden that may be incurred in your attempt to respond to the deficiencies. We believe that we have considered the least burdensome approach to resolving these issues. If, however, you believe that information is being requested that is not relevant to tie regulatory decision or that there is a less burdensome way to resolve the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.htm!
5ee-
evY\
"SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION K040627 Reviewer: Elizabeth L Frank Division/Branch: DGRND/ORDB Device Name: DePuyASRT odlrActbla u Sse
Product To Which Compared (5 10(K) Number If Known): K965156, K002883. K003523, K021349 YES NO 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Is Product A Device Is Device Subject To 510(k)? Same Indication Statement? Do Differences Alter The Effect Or Raise New Issues of Safety Or Effectiveness?
Descriptive Characteristics Precise Enough? New Types Of Safety Or Effectiveness Questions? Accepted Scientific Methods Exist? Performance Data Available? Data Demonstrate Equivalence? X X X X X X X X if NO =Stop If NO - Stop
If YES -Go To 5
If YES - Stop NE
If YES If YES Go To 7 Go To 8
= =
To 10 If NO If YES - Stop SE
=-Go
If YES
Stop NE
If NO - Stop NE If NO - Request Data IFinal Decision:
Note: In addition to completing the form on the LAN, 'yes" responses to questions 4, 6, 8, and 1I, and every "no" response requires an explanation.
K040627
Internal Administrative Form
1. Did the firm request expedited review? 2. Did we grant expedited review? 3. Have you verified that the Document is labeled Class III for GMP purposes? 4. If,not, has POS been notified? 5. Is the product a device? 6. Is the device exempt from 510(k) by regulation or policy? 7. Is the device subject to review by CDRH? 8. Are you aware that this device has been the subject of a previous NSE decision? 9. If yes, does this new 510(k) address the NSE issue(s), (e.g., performance data)? 10.Are you aware of the submitter being the subject of an integrity investigation? 11. If,yes, consult the ODE Integrity Officer. 12. Has the ODE Integrity Officer given permission to proceed with the review? (Blue Book Memo #191-2 and Federal Register 90N0332, September 10, 1991.
YES
NO
A//
/LA
To: From: Date: Device: Company:
Contact:
K040627 Elizabeth Frank, Biomedical Engineer, M.S. FDA/CDRI/ODE/DGRND/Orthopedic Devices Branch (HFZ-4 10) May 24, 2004 DePuy ASRTM Modular Acetabular Cup System Product Code: 87 KWA (21 CFR 888.3330), Class III DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Warsaw, IN 46581-0988 Natalie Heck, Manager, Regulatory Affairs Phone: 574-372-7469, Fax: 574-3714939, Email: nheckdpows.jnj.com
Recommendation: The file will be placed on hold and the sponsor will be sent an Al letter with the deficiencies listed at the end of the memo asking for clinical data. Review: 1. Administrative Requirements: The submission contains a 510(k) Summary, a Truthful and Accuracy Statement and Indications for Use page. Device Description: Acetabular Shell Component: The acetabular component is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one-piece cup with Porocoat porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shell has a highly polished, superfinished internal bearing surface, and is available with outer diameter sizes 44-70 mm in 2mm increments. There is no separate liner component to this system, as it is a one-piece acetabular shell used with a unipolar femoral head and a taper sleeve adapter. The shell component uses the same Porocoat process used for the predicate device (K002883 & (b) (4) K003523). The coating consists of of the properties of the Porocoat porous coating: (b) (4) Below is a summary (b) (4)
2.
hydroxyapatite (HA) coating. The outer surface of the cup has the addition of a (b) (4) ' Characteristics of the HA coating on the CoCrMo Porocoat substrate are found in (b) (4) (Ca 5(PO4)3 OH) ceramic. (b) (4) The HA material conforms to ASTM F1 185-88 for hydroxyapatite
K040627 Pg. 1 of 6
9Go
Fernoral Component: The uni femoral head is manufactured from cast high carbon cobalt-chromium-molybdenum (CoCrMo) alloy and is available in a range of diameters from 39-63mm in 2mm increments. All of the uni femoral heads have an internal taper which mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13 tapers corresponding to the external tapers on DePuy femoral stems. The femoral heads have a highly polished, superfinished exterior bearing surface, and articulate with corresponding one-piece metal acetabular cups. Taper Sleeve Adapters: The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity of using taper sleeve adapters in two taper options allows for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems. The ASR 12/14 taper sleeve adapters are manufactured from forged cobalt-chrome-molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters are manufactured from wrought CoCrMo alloy and were previously cleared in the Ultima Unipolar Head and Sleeve (K965156) and are offered in neck length options of +0, +6, and +12. A list of all sizes of the DePuy ASRTM Modular Acetabular System are including in Exhibit 1, with a list of compatible components. Device photographs are included on page 13 and engineering drawings are provided in Exhibit 2. The following table summarizes the similarities and differences between the subject and predicate devices. The subject device is not SE to DePuy's Pinnacle predicate device. The ASR Uni Femoral Head and Acetabular Cup System is considered a new metal on metal system that will require clinical data. See deficiency #1. There are a lot of similaritiesbetween the subject device and the (b) (4) (b) ( The design appears to be the design as the b that will fit most femoral stems. The acetabular cup in this submission is the identical (4) ( . The sponsor must also identify the clearances and ) acetabular cup in the b the system. tolerances that will be allowed with ( ) 4 (~ ~ db edical : , Dc~uy Ultima ~ D6? s ~ ~ Design/Material:..) n~ ~ ~~~~iWP 4 ~~a unipotitrXdaipfer ~ ?, ~ ~ ~ ~ ~ ~ ~ <N acn ) e ; +
F.
Material: :<
PrSysR"'tem
9'
ifry tm,
X9651 N/A
~<K
Cast High Carbon Coalloy ~,-~ ,,Cr-Mo
K Diameters! :5/Q~i :,~; :________________ '(in Articulation ::' -,uirememtA: Superfimshed surface R
Cast High Carbon Wrought Co-Cr-Mo alloy Co-Cr-Mo alloy (ASTM F-75) F-1537) (ASTM F-75)(ASTM 38-54 mm 28mm & 36 mm ,39-63 mm ~~~~~~~~~~~~~~~~~~~N/A (in 2mm increments) 2mm increments) Superfinished surface Superfinished surface
N/A 11/13 external taper sleeve adapters manufactured from wrought CoCrMo alloy (ASTM F-1537) Taper Sleeve
TaSier eeAdaptes:> TaperOoeometr 12/14 external taper sleeve adapters Femoral Heads. manufactured 12/14 and 11/13 from wrought internal tapers CoCrMo alloy F-799) (ASTM Taper/Neck Taper Sleeve Adapters: 28mm Femoral Heads: K040627
Femoral Heads: 12/14 internal taper Cast High Carbon CoCrMo alloy ~~~~(ASTM F-75) Femoral Heads:
Pg. 2 of 6
:RO
12/14 taper: +l.5, +5,+8.5
~ i??-~~
~~~ ~ ~
11 3 apr +6, ~~+0,+12 (se Ultima taper sleeve adapters) nee h+6,
Comonn:
12/14 taper: +1.5, +5, +8.5 11/13 taper: +0, +3, +6 36mmn Femoral Heads: 12/14 taper: -2, +1.5, +5, +8.5, +12 11/13 taper: +0, +3, +12
12/14 taper: -3.5, 0, +3.5
Adapters: 11/13 taper: +0, +6, +12
e+9
Cast High Carbon Co-Cr-Mo alloyN/A (ASTM F-75) Porous coated N/A N/ N/A
Mated
oD:~p'at'mg:,i&f,
ji
Outer Diameter: Inner Diaifietert?>:
Cast High Carbon Co-Cr-Mo alloy ) F-75 ~:~ (ASTM PorocoatV Porous Coating with DuoFix T HA coating 44-70mm ~:%, i > .Sm 2mm increments) 39-63mm Superumisbed Surface
Wrought CoCrMo alloy (ASTM F-1537) N/A

"g
46-64mm 48-66mm ~~~~~~~~~~~~~~N/A (in 2mm increments) (in 2mm increments) 36-54mm 28 & 36mm Superfinished Surface Superfinished Surface
N/A
Re uirements
3.
uefihd ufc
Intended Use: The DePuy ASRTM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, .collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The indications for use statement is the same as the Pinnacle Metal-On-Metal Acetabular Cup Liner (K003523), except it has been revised from the acetabular component in total hip replacement to the entire total hip replacement.
4.
Sterilization: Radiation Type: Gamma Radiation Source: (b) (4) Minimum Dosage: (b) (4) Sterility Assurance Level: (b) (4) Sterility Validation Method: Pyrogen-Free: No claims will be made
(b) (4) (b) (4)
5.
Labeling: The instructions for use and draft labels are provided in Exhibit 3. Testing:
6. (b) (4)
K040627 Pg. 3 of 6
(b) (4)
7.
Sponsor's Information in support of SE: DePuy Pinnacle Metal-on-Metal Acetabular Cup Liner (K003523, K002883) Wright Medical Metal TRANSCEND Articulation System (K021349) DePuy Ultima Unipolar Head and Adapter Sleeves (K965156) Review of other 510(k)s/IDEs: Wright Medical Metal TRANSCEND Articulation System (K004043/S001) Corin USA Cormet Large Diameter Metal on Metal Hip System IDE (G030265) Summary: The sponsor has not proven their device is SE to the Pinnacle Metal on Metal System. Clinical data is necessary for this new metal on metal system. The new device is very similar to the (b) (4) ( The sponsor has been asked to clarify the differences appropriate bench top testing. The sponsor will be sent an Al letter between the two systems and complete b ) with the deficiencies below. ( 4 Contact History/Requests for More Information: ) 5/14 - Spoke with Natalie Heck to discuss design and to confirm that this is a new system.
8.
9.
10.
AthLF~~~~~~, (Date) Orthopedic Devices Branch Division of General, Restorative and Neurological Devices
Eliz~t~et L. Frank, M.S.
L tzto
K040627 Pg. 4 of 6
Deficiencies: l. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), while your predicate PinnacleTM Metal-on-Metal Acetabular Cup (K003523 & K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM F-1537). The change in material alters the articulating surfaces of your system creating new safety concerns. Although the Wright Medical TRANSCEND Articulation System (K021349) is composed of Cast Co-Cr-Mo alloy (ASTM F-75), this system had its own clearances and tolerances, which were proven to be safe and effective through their own clinical data. Your diametrical clearances and tolerances have not been identified in your submission. In addition, you have proposed 39-63mm inner diameters for your acetabular cups with matching femoral head diameters. Your Pinnacle predicate only exists in 28 and 36 mm sizes and the Wright TRANSCEND System is 38-54mm. It is unknown what effect increasing the diameter to 62mm will have on the clinical use of the system. While we have allowed several small increases in diameters with appropriate bench top testing, we are unsure how large is actually safe for clinical use. All of these design differences can significantly influence the clinical outcomes for metal-on-metal hip arthroplasty devices. These changes present safety concerns that we feel cannot be addressed by preclinical testing and must be addressed by clinical data to support a determination of substantial equivalence of your 5 10(k). If the clinical data are collected in the US, the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE) application. We recommend that you contact us prior to submission of an IDE to address any questions related to the clinical study design. 2. (b) The test reports submitted in Exhibit 4 refer to a (4) Please clarify which components of this system are identical to the components in the (b) (4) (b) (4) (b) and which are unique to this submission. Please complete approriate (4) the worst-case scenario for the components in this submission or provide an engineering (b) (4) on (b) (4)
3.
The submission states, "The modularity of using taper sleeve adapters in two taper options allow for a reduced number of femoral head components while offering various femoral head offsets and compatibility with multiple femoral stems." The size of the femoral head can affect the fatigue strength of the femoral stem in vivo. Therefore, we believe fatigue testing to assess the strength of the worst case femoral stem, coupled with the worst case femoral head, is necessary to establish the safety and effectiveness of the system. Please provide an engineering justification or complete fatigue testing on your five worst case head/stem constructs. Please justify your choice for the worst case head/stem construct (e.g., head with largest lateral offset, stem most likely to fail in fatigue). The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The taper sleeve adapter results in a somewhat hollow head design which may be susceptible to additional failure modes (i.e. fatigue fracture involving the cylindrical shaft in which the Sleeve Adapter fits) that a solid head would not , to assess the strength of the cylindrical sleeve adapter shaft, is encounter. We believe (b) (4) (b) (4)
4.
5.
In addition to (b) (4) The test reports included in Exhibit 4 address fretting, and loosening in metal-on(b) (4) have been known to cause component seizing metal hip systems. Therefore, we believe the friction between the bearing surfaces is an important parameter in assessing the safety and effectiveness of a metal-on-metal hip system. Please provide (b) (4)
K040627 Pg. 5 of 6
(b) (4) testing.
K040627 Pg. 6 of 6
510(k) ,SUBSTANTIAL EQUIVALENCE" iECISION-MAKING PROCESS
0~~~~
about New or Marketed d as Needed R e equeste D evic sNe I 1ijtCIt itin )e Indicatioi 5 ehive Sane uent'? NO I-
ested as Needed Safety and Effectivencss)Y?* DeviceRW.

HIas
Inteded )o (tie DilIuzreas Alter (tice TherapcutieDiagnostic/etc. Elllzet (in Deciding. May Consider Impact on
YES
Not Substntial lv Ejquivaleti Deternination
New Device
Sa
Intended
Equivalen
NO
N ice vy as
Use and May be '-Subs
New Intended Use S V~eameNe lo t Char edristics. NO 'Icelinlo e DIesin. Materi <etc? w Device I~ yeSa5 Noes
Could the ew
o ), RaiseNewTypesofSafety YES or Effectiveness Questions?
Characteristics
Aflect Safety or Effecti eless?
Dothe New Characteristics
NO
Dcriptve Are ithe -- tic~ recise Enough ivalence?
NO
N NO
( NO NO A re
Ar ~founmanee Data Ases Dia Availabl
Do Accepted Scientific
Methods Exist for Assessing Eftects of the New Characteristics? NO
YES
(D
'~~~~~jYS NO
PerfoataRee Data Required
Are perfonlance Data Available To Assess Effects of New Characteristics? ***
Perfbri
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ions-rate
Dperformance '. YES
Data Demonstrate 4 Equivalence? NO
Io
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otin * Si 0(1(k) Stbc ci ssiru 5 iulalrkcetnd I "piedicate
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betweei requests additioaal inobrmation it the relalionship devices to marketed devices -DA ~ devices is unclear. (,ic,-A ...cidiiecits or reclassitied post-Auitcidiilents)
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elassiticatioil files. or (lie liherature. Data ittlahe iin the 510(k). other 5;10(k s thCenter's

Radiological Health
December 03, 2004
Rockville, Maryland
20850
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 WARSAW, IN 46581 ATTN: NATALIE HECK
510(k) Number: K040627

DEPUY ASR
Product: MODULAR
ACETABULAR CUP
SYSTEM
The additional information you have submitted has been received.

We will notify you when the processing of this submission has been
completed or if any additional information is required. Please
remember that all correspondence concerning your submission MUST
be sent to the Document Mail Center (HFZ-401) at the above
letterhead address. Correspondence sent to any address other than
the one above will not be considered as part of your official
premarket notification submission. Also, please note the new
Blue Book Memorandum regarding Fax and E-mail Policy entitled,
"Fax and E-Mail Communication with Industry about Premarket Files
Under Review. Please refer to this guidance for information on current
fax and e-mail practices at www.fda.gov/cdrh/ode/a02-Ol.html.
The Safe Medical Devices Act of 1990, signed on November 28, states
that you may not place this device into commercial distribution
until you receive a letter from FDA allowing you to do so. As in
the past, we intend to complete our review as quickly as possible.
Generally we do so 90 days. However, the complexity of a submission
or a requirement for additional information may occasionally cause
the review to extend beyond 90 days. Thus, if you have not received
a written decision or been contacted within 90 days of our receipt
date you may want to check with FDA to determine the status of your
submission.
Sincerely yours,
Marjorie Shulman
Radiological Health
It4
*Deduy
Traditional
510(k)
Submission
K040627/5
DePuy ASRTM Modular Acetabular Cup System
Request for Additional Information Dec 2, 2004
700 ORTHOPAEDIC
DRIVE
WARSAW IN 46581.008
*DeRiy
510(k): Preinarket Notification December 2, 2004 Food and Drug Administration CDRI-IODE Document Mail Center (HFZ-401)
Rockville, MD 20850
Attn: Ms. Elizabeth Frank
Tm Re: Additional Information- K040627 DePuy ASR Modular Acetabular Cup Systemn
DePuy Orthopaedics, Inc. P o 8 700 Orthopaedic Drive Warsaw, Indiana 46581 -0988 USA Tel: +1(574) 267 8143
Dear Ms. Frank: to the DePuy Orthopaedics, Inc. submits the enclosed documentation in duplicate as an addendum FDA. This DePuy ASR~ Modular Acetabular Cup System, K(040627, currently under review by made by written request submission is made to comply with the request for additional information addendum. dated June 03, 2004. Please find the questions and corresponding responses in the attached this 5 10(k) Pursuant to 21 CFR 807.95(c) (3), DePuy considers our intent to market this device and such. DePuy submission to be confidential commercial information and requests that FDA treats it as to market these devices. We has taken precautions to protect the confidentiality of the intent 18 U.S.C. 1001 understand that the submission to the government of false information is prohibited by and 21 U.S.C. 331(q). commercial DePuy Orthopaedics acknowledges that the introduction of this device into domestic the 510(k)
by the Food and Drug distribution will be contingent upon written clearance of Administration.
questions Thank you in advance for your consideration of our application. If there are any further (574) 371 -
regarding this submission, please feel free to contact me via phone (574) 372-7469, fax 4987, or email at nheckratdtwus n'cm
Regards,
NatleHc Manager, Regulatory Affairs.j DePuy Orthopaedics, Inc.
_j ~
/j
M Addendum to DePuy ASR T Modular Acetabular Cup System 510(K), K040627 Written request for Additional information, June 03, 2004; extension requested for December 03, 2004: ---Question la: The change in material alters the articulating surfaces of your system creating safety concerns (ASR- Cast CoCr; Pinnacle- Wrought CoCr)
------------------------- -------------------------------
(b) (4)
Response la:
We conclude from the testing performed that there is no increase in safety concerns based upon the change from wrought CoCr to cast CoCr for the ASR lUni head and cup bearing couple. As further support for the material choice of the subject device, we have included summaries of the following journal articles: Title: The Otto Aufrauc Award. Wear and lubrication of metal-on-metal hip implants. Author(s): Chan FW, Robyn JD, Medley JB, Krygier JJ, Tanzer M. Source: PMID: 10611857 [PubMed - indexed for MEDLINE]
Volume: Clini Orthop.l999 Dec. (369)10-24
Department of Biomedical Engineering, McGill University, Montreal, Quebec, Canada. The implication of polyethylene wear particles as the dominant cause of periprosthetic osteolysis has created a resurgence of interest in metal-on-metal implants for total hip arthroplasty because of their potential for improved wear performance. Twenty-two cobalt chromium molybdenum metal-on-metal implants were custom-manufactured and tested in a hip simulator. Accelerated wear occuared within the first million cycles followed by a marked decrease in wear rate to low steady-state values. The 3 volumetric wear at 3 million cycles was very small, ranging from 0. 15 to 2.56 mm for all implants tested. Larger head-cup clearance and increased surface roughness were associated with increased wear. Independent effects on wear of material processing (wrought, cast) and carbon content were not identified. Implant wear decreased with increasing lambda ratio, a parameter used to relate lubricant film thickness to surface roughness, suggesting some degree of fluid film lubrication during testing. This study provided important insight into the design and engineering parameters that affect the wear behavior of metal-on-metal hip implants and indicated that high quality manufacturing can reproducibly lead to very low wear. As quoted in the text, "Certainly, with similar ranges in clearance
IL
and roughness values, no statistical difference between the high C wrought and high C cast implants was identified." Title: Engineering issues and wear performance of metal on metal hip implants. Author(s): Chan FW, Robyn JD, Medley JB, Krygier JJ, Yine S, Tanzer M. Source: PMID: 8981885 [PubMed - indexed for MEDLINE] Volume: Clin Orthop. 1999 Dec.; (333) 96-107 Jo Miller Orthopaedic Research Laboratory, Montreal General Hospital and McGill University, Quebec, Canada. A major concern in total hip arthroplasty is the generation of polyethylene wear particles at the articulating surfaces and resulting macrophage mediated periimplant osteolysis. There is renewed interest in metal on metal bearings as a solution to this problem in view of their potential for greatly of improved wear performance. Using a commercially available hip simulator, the wear performance metal on metal femoral head and acetabular cup combinations was evaluated and various parameters 2 affecting metal on metal implant wear were identified. Nine implants custom manufactured from bovine serum as medical grades of CoCrMo alloy (ASTM F1537-95 and F75-92) were tested within the lubricant to 3 million cycles (equivalent to approximately 3 years of service in vivo). The progressive wear of the components was determined by gravimetric methods at approximately every which 300,000 cycles. The wear rates were characterized by an initial period of accelerated wear after The presence of calcium phosphate a lower steady state wear rate was observed for subsequent cycles. films on the component surfaces, the microstructure of the lower carbon wrought alloy, and increased to effective radii (decreased diametrical clearances) were identified as factors that may be favorable be improved wear performance. The extent of the effect on wear of each parameter, however, cannot study in which parametric changes are more tightly discerned at this point and necessitates a mitigate controlled. The present study suggests that the use of metal on metal articulating surfaces may the problem of osteolysis by offering improved wear performance. Question 1k submission. Your diametrical clearances and tolerances have not been identified in your
cups) Responselib: The diametrical clearances for all femoral implants (femoral heads to acetabular are given in the table below.
(b) (4)
Femoral mln Size
Diametrical Clearance (mm)
(b) (4)
(b) (4)
3s-
Representative Product Layout
DERUH
(b) (4)
ASPTM MODULAR
PRODDUOT LAYCLI
Note: In addition to the requested information, DePuy would like to make a correction to the part number listing for the Uni Femoral Head Size 47mm, and the description to the taper sleeve adapters in the components table. DePuy ASRTM Modular Acetabular System Description Uni Femoral Head Size 39mm Uni Femoral Head Size 41mm Uni Femoral Head Size 43mm Uni Femoral Head Size 45mm Uni Femoral Head Size 46mm Uni Femoral Head Size 47mm Uni Femoral Head Size 49mm Uni Femoral Head Size 51mm Uni Femoral Head Size 53mm Uni Femoral Head Size 55mm Uni Femoral Head Size 57mm Uni Femoral Head Size 59mm Uni Femoral Head Size 61mm Uni Femoral Head Size 63mm Acetabular Shell size 44mm Acetabular Shell size 46mm Acetabular Shell size 48mm Acetabular Shell size 50mm Acetabular Shell size 52mm Acetabular Shell size 54mm Acetabular Shell size 56mm Acetabular Shell size 58mm Acetabular Shell size 60mm Acetabular Shell size 62mm Acetabular Shell size 64amm Acetabular Shell size 66mm Acetabular Shell size 68mm Acetabular Shell size 70mm Taper Sleeve Adapters 12/14 +2 Taper Sleeve Adapters 12/14 +5 Taper Sleeve Adapters 12/14 +8 Sizing 38.50D
40.5 0D
42.500
44.5 OD
45.5 OD
46.5 OD
48.5 0D
50.50D
52.500
54.49 OD
56.48 OD
58.46OD
60.44OD
62.43 OD
44 OD x 38.6 ID 46 OD x 40.60 ID 48 OD x 42.60 ID 50 OD x 44.60 ID 52 OD x 45.60 [D 54 OD x 46.60 ID 56 OD x 48.60 ID 58 OD x 50.60 ID 60 OD x 52.60 1D 62 OD x 54.60 1D 64 OD x 56.60 1D 66 OD x 58.60 ID 68 OD x 60.60 ID 70 OD x 62.60 ID +2mm neck Ing, 12/14 taper +5mm neck Ing, 12/14 taper +8mm neck Ing, 12/14 taper Catalog Number 999800139 999800141 999800143 999800145 999800146 999800147 999800149 999800151 999800153 999800155 999800157 999800159 999800161 999800163 999803944 999804146 999804348 999804550 999804652 999804754 999804956 999805158 999805360 999805562 999805764 999805966 999806168 999806370 999800102 999800105 999800108 Part Number 999890239
999890241
999890243
999890245
999890246
999890247
999890249
999890251
999890253
999890255
999890257
999890259
999890261
999890263
999800744
999800746
999800748
999800750
999800752
999800754
999800756
999800758
999800760
999800762
999800764
999800766
999800768
999800770
999800312
999800315
999800318
An updated sleeve adapter drawing is included as an exhibit to this response.
%5
Question lc: It is unknown what effect increasing the diameter to 63mm will have on the clinical use of the system (ASR- 39 to 63mm; Wright 38 to 54mm) Response lc: The expected performance of the larger diameter heads/cups is supported by the following:
-
(b) (4)
We conclude from the analyses performed that there is no increase in safety concerns based upon the larger head diameters of the subject device as compared to the predicate device. As further support for the range of head diameters of the subject device, we have included abstracts of the following articles: Title: Analysis of Fluid Film Lubrication in Artificial Hip Joint Replacements with Surfaces of High Elastic Modulus Author(s): Z M Jinl; D Dowson ; J Fisher 2 Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine Volume: 211 Page: 247- 256 DOI: 10.1243/0954411971534359 Publisher: Professional Engineering Publishing Abstract: Lubrication mechanisms and contact mechanics have been analysed for total hip joint replacements made from hard bearing surfaces such as metal-on-metal and ceramic-on-ceramic. A similar analysis for ultra-high molecular weight polyethylene (UHMWPE) against a hard bearing surface has also been carried out and used as a reference. The most important factor influencing the predicted lubricating film thickness has been found to be the radial clearance between the ball and the socket. Full fluid film lubrication may be achieved in these hard/hard bearings provided that the surface finish of the bearing surface and the radial clearance are chosen correctly and maintained. Furthermore, there is a close relation between the predicted contact half width and the predicted lubricating film thickness. Therefore, it is important to analyse the contact mechanics in artificial hip joint replacements. Practical considerations of manufacturing these bearing surfaces have also been discussed. The Institution of Mechanical Engineers 2004 Title: The effect of femoral head diameter upon lubrication and wear of metal-on-metal total hip replacements Author(s): S L Smith'; D Dowson 2 ; A A J Goldsmith 3 Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine Volume: 215 Page: 161 - 170 DOI: 10.1243/0954411011533724
Publisher: Professional Engineering Publishing Abstract: It has been found that a remarkable reduction in the wear of metal-on-metal hip joints can be achieved by simply increasing the diameter of the joint. A tribological evaluation of metalon-metal joints of 16, 22.225, 28 and 36 mm diameter was conducted in 25 per cent bovine serum using a hip joint simulator. Thejoints were subject to dynamic motion and loading cycles simulating walking for both lubrication and wear studies. For each size ofjoint in the lubrication study, an electrical resistivity technique was used to detect the extent of surface separation through a complete walking cycle. Wear of each size ofjoint was measured gravimetrically in wear tests of at least 2x 106 cycles duration. Joints of 16 and 22.225 mm diameter showed no surface separation in the lubrication study. This suggested that wear would be proportional to the sliding distance and hence joint size in this boundary lubrication regime. A 28 mm diameterjoint showed only limited evidence of surface separation suggesting that these joints were operating in a mixed lubrication regime. A 36 mm diameterjoint showed surface separation for considerable parts of each walking cycle and hence evidence of the formation of a protective lubricating film. Wear testing of 16 and 22.225 mm diameter metal-on-metal joints gave mean wear rates of 4.85 and 6.30 mm 3/106 cycles respectively. The ratio of these wear rates, 0.77, is approximately the same as the joint diameters ratio, 16/22.225 or 0.72, as expected from simple wear theory for dry or boundary lubrication conditions. No bedding-in was observed with these smaller diameter 6 joints. For the 28 mm diameter joint, from 0 to 2x 10 cycles, the mean wear rate was 1.62 mm 3/106 cycles as thejoints bedded-in. Following bedding-in, from 2.0x10 to 4.7x 106 cycles, the wear rate was 0.54 mm 3/106 cycles. As reported previously by Goldsmith et al. in 2000, the mean steady state wear rate of the 36 mm diameterjoints was lower than those of all the other diameters 3 at 0.07 mrm /106 cycles. For a range ofjoints of various diameters, subjected to identical test conditions, mean wear rates differed by almost two orders of magnitude. This study has demonstrated that the application of sound tribological principles to prosthetic design can reduce the wear of metal-on-metal joints, using currently available materials, to a negligible level. The Institution of Mechanical Engineers 2004 Question 2a: Clarify which components of this system are identical to the components in the resurfacing IDE study and which are unique to this submission Response 2a:
(b) (4)
Component
510(k)
IDE
(b) (4)
Question 2b: Complete appropriate wear and corrosion testing on the worst-case scenario for the components in this submission or provide an engineering rationale explaining why the current test reports are adequate. Justify your choice for the worst case femoral head/acetabular cup construct.
(b) (4)
Question 3: The size of the femoral head can affect the fatigue strength of the femoral stem in vivo. worst case femnoral stem, coupled with the worst Provide (b) (4) case femoral head or an engineering justification explaining why the current test reports are adequate. Response 3: It is not the size of the femoral head that affects the fatigue strength of the femoral stem but rather is performed with the worst-case offset, the femoral head offset. Typical stem (b) (4) 32mm +17, because this creates the longest moment arm.
(b) (4)
Question 4: The taper sleeve adapter results in a somewhat hollow design, which may be susceptible to additional failure modes that a solid head would not encounter. Provide an engineering justification or a complete test report containing ( heads with the worst case head design under the worst case (b) (4)
b ) Response 4: Please find attached test report RDR063/04 " ( (b) 4 (4) ) (b) (4)
(b .) (4 )
d.
(b) (4)
Question 5: Provide system both before and after the devices undergo (b) (4)
(b) (4)
e data on the
(b) (4)
10
(b) (4)
11
Revised Sleeve Adapter

Engineering Drawing
12
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RDR04-063 .doc
RESEARCH DEPARTMEN
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VP 000041
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datn

RadiologiCal Health
Device Evaluation
Office of
(HFZ-40l)
Document Mail Center
May 24, 2005
Rockville, Maryland
20850
DEPUlY ORTHOPAEDICS, INC.

700 ORTHOPAEDIC DR.
P.O. BOX 988
WARSAW, IN 46581
ATTN: NATALIE HECK
510(k) Number: K040627

DEPUY ASR
Product: MODULAR
ACETABULAR CUP
SYSTEM
received.
The additional information you have submitted has been has been
We will notify you when the processing of this submission information is required. Please
if completed or
any additional MUST
remember that all correspondence concerning your submission the above
the Document Mail Center (HFZ-401) at be sent to
other than
to letterhead address. Correspondence sent
any address as
part of your official
above will not be considered the one
the new
premarket notification submission.
Also, please note Fax and E-mail Policy entitled,
Blue Book Memorandum regarding Files
"Fax and E-Mail Communication with Industry about Premarket this guidance for information on current
Under Review. Please refer to
fax and e-mail practices at www.fda.gov/cdrh/ode/aO2-Ol.html.
28, states
The Safe Medical Devices Act of 1990,
signed on November into cormmercial distribution
that you may not place this device do so. As in
until you receive a letter from FDA allowing you to as possible.
the past, we intend to complete our review as
quickly of a submission
Generally we do
so 90 days. However, the complexity for additional information may occasionally cause
or a requirement
extend beyond 90 days. Thus, if you have not received
the review to
our receipt
of
a written decision or been contacted within 90 days with FDA to determine the status of your
check date you may want to
submission.
contact the
If you have procedural or policy questions, please and Consumer Assistance
Division of Small Manufacturers International (800) 638-2041,
at (DSMICA) at (301) 443-6597 or
their toll-free number (301) 594-1190.
contact me at or
Sincerely yours,
Marjorie Shulman
Radiological Health
1-3
0 /'~ 9k-
7/6
*De~uy
Traditional
510(k)
Submission
K040627
DePuy ASR Th Modular Acetabular Cup

System
Request for Additional Information
May 23, 2005
700 ORTHOPAEDIC DRIVE WARSAW IN 46581-gWW
*De~uy
a o~t~ntt
4
4Olcompany

700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581-0988 USA
Tel: +1(219) 267 8143

510(k): Premarket Notification May 23, 2005 Food and Drug Administration CDRHIODE Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850 Ann: Ms. Elizabeth Frank Re: Additional Information - K040627 DePuy ASR Dear Ms. Frank: addendum to the
DePuy Orthopaedics, Inc. submits the enclosed documentation in duplicate as an by FDA.
This
M DePuy ASR T Modular Acetabular Cup System, K040627, currently under review additional information made by letter request
submission is made to comply with the request for on January 26, 2005. device and this Pursuant to 21 CFR 807.95(c) (3), DePuy considers
our intent to market this FDA treats it as
510(k) submission to be confidential commercial information and requests that to market these
such. DePuy has taken precautions to protect the confidentiality of the intent of false information is prohibited devices-
We understand that the submission to the government by 18 U.S.C. 1001 and 21 U.S.C. 331(q).
commercial
DePuy Orthopaedics acknowledges that the introduction of this device into domestic clearance of the 510(k) by the Food and Drug
distribution will be contingent upon written Administration.
further questions
Thank you in advance for your consideration of our application. If there are any fax (574)
regarding this submission, please feel free to contact me via phone (574) 372-7469, 3714987, or email at nheckqdpovs.ini.com.
Regards,
T M
Tel: +1(219) 267 8143
Manager, Regulatory Affairs DePuy Orthopaedics, Inc.
A Rationale and Technical Overview is provided to identify the history and design rationale specific to the DePuy ASRTM Modular Acetabular Cup System, and metal-onmetal acetabular bearing couples in general.
Rationale and Technical Overview Of the ASR Modular Acetabular Cup System
(b) (4)
It
1
Tribology and Design Parameters of MOM Wear Couples

(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
TM Addendum to DePuy ASR Modular Acetabular Cup System 510(K), K040627 Letter Request for Additional Information, January 26, 2005:
(b) (4)
Question 1:
Response la: ASTM F-75 requires that the carbon content of the cobalt chromium molybdenum raw (CoCrMo) casting alloy material be within the range of 0% - 0.35%. The internal a carbon material specification for the subject ASRTM uni femoral head and cup specifies raw material (b) (4) A copy of the internal content within the range of specification IRM 103-21-001 is provided in the rationale and technical overview. content Adherence to this internal specification guarantees the device will have a carbon of the range required by the ASTM specification. within the (b) (4)
(b) (4)
that there Based on the carbon content requirements and testing performed, we conclude from wrought CoCrMo to cast is no increase in safety concerns based upon the change CoCrMo for the ASR uni head and cup bearing couple.
(b) (4)
h. The diametrical clearances and tolerances provided in Supplement I rane from
Response lb: Please note the stated predicate Pinnacle Metal-on-Metal Acetabular Cup System clearance range in the deficiency letter require correction. The minimum and maximum clearances (microns) for the approved metal-on-metal systems and the ASR modular system are summarized in the table below.
(b) (4)
The ASR Modular Acetabular Cup System design has clearances within the range of those for previously cleared metal-on-metal devices. Furthermore, the overall range of clearances for the ASR Modular device is equal to that of the Wright Medical TRANSCEND device (1 10 microns).
(b) (4)
10
(b) (4)
performed, we conclude that there is no Based on the bearing design and (b) (4) increase in safety concerns based upon the increase in diametrical clearance. has
(b) (4)
(b) (4) Based on our concerns regarding the changes in (b) (4) , we believe clinical data are necessary to support a new metal-onwould metal system. If the clinical data-are collected, in the US, the clinical data device exemption need to be collected as part of a FDA-approvcd investigational of an (IDE) application. We recommend that you contact us prior to submission IDE to address any questions related to the clinical study design.
Response lc: diameter As explained in the rationale and technical overview, increasing the bearing enhances the wear performance of a metal-on-metal articulation because larger ASR elastohydrodynamic lubrication is more easily achieved. Therefore, the Pinnacle bearing diameters represent a better wear scenario than the predicate 36mm larger diameter heads offer greater Metal-on-Metal Acetabular Cup System. Additionally, resistance to subluxation and dislocation as well as improved range of motion.
(b) (4)
RDR 117/04
(b) (4)
2:1
(b) (4)
We conclude from the analyses performed that there is no increase in safety concerns based upon the larger head diameters of the subject device as compared to the predicate device.
(b) (4) devices, 2. Several of the provided test reports were performed using the large diameter and these results are being used to support the articulation of unipolar femnoral heads and ASR acetabular cups in the subject submission. In (b) (4)
hile
(b) (4) assembly. Differences between the (b) will affect the loading of the system, as well as wear patterns, We do not believe (4) preclinical testing of a (b) (4) can be appropriately substituted as that preclinical testing for a total hip system. Therefore the following reports submitted in Supplement I are not considered to be applicable to this submission and the original deficiencies referencing these reports remain: (b) (4)
Response 2: By the nature of their design, hip joint replacement devices transmit load through the bearing surface, specifically the joint contact area. This is no different whether the femoral component takes the form of a modular head and femoral stem or a surface (b) (4) replacement device. In
(b) (4)
12
applicable to the subject device because the two systems utilize the identical acetabular (b) (4) is identical in bearing cup and the femoral component for the design (material, outer diameter, surface finish and bearing clearance) to the subject large diameter unipolar femoral heads. We believe that the following test reports are applicable based on the stated reasons.
(b) (4)
13
(b) (4)
3. In response to Question 5, you have submitted (b) (4) (b) (4) data on the resurfacing components of this system. As described above, we do (b) (4) provide not believe preclinical testing comparable results, due to differences in in vivo loading conditions. Therefore, the original deficiency remains and both( b (b) (4) isrequested. In addition, the provided (b) (4) testing for ) the acetabular cup does not address our concerns regarding (b) (4) ( (b) (4) .4
)
Response 3: In response to testing the response to Question 2 above.

(b) (4)
(b) (4)
m, please see the
14
(b) (4)
15
4. a)
Data companng ranges of motion, shell-liner assemblyfdisassembly forces, acetabular shell/inscrt locitng mechanism and design to that of the metal/metal predicate Pinnacle system (K003523, K002883).
Response 4 a) Ranges of Motion: Pinnacle Metal-on-Metal Bearing ID

(b) (4)
ASR Modular ROM Bearing ID Smallest Shell OD ROM
Smallest Shell OD
The DePuy ASR T M Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, and a taper sleeve adapter. The acetabular cup consists of a cobalt-chromium molybdenum (CoCrMo) alloy onepiece cup with Porocoat porous coating. The outer porous coated surface of the cup has the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. The uni femoral head is manufactured from cobalt-chromium molybdenum (CoCrMo) alloy. The uni femoral heads have an internal taper which mates with a taper sleeve adapter. The femoral heads articulate with the corresponding one-piece metal acetabular cups. The taper sleeve adapters are manufactured from cobalt-chromium molybdenum (CoCrMo) alloy.
M The DePuy Pinnacle'T Metal-On-Metal (MOM) Acetabular Cup System is comprised of a metal acetabular shell, a metal acetabular cup insert, and modular metal femoral heads.
The outer titanium aluminum vanadium (Ti-6A1-4V) alloy acetabular cup is a hemispherical stepped and porous-coated shell with three dome screw holes, an apical hole used for visualization, and a peripheral female taper. The Porocoat porous coating on the shell is commercially pure titanium. The superfinished metal liner is manufactured from cobalt-chromium molybdenum (CoCrMo) alloy. The metal insert mechanically locks with the metal shell via a taper junction. The modular heads are superfinished cobalt-chromium molybdenum (CoCrMo) alloy metal femoral heads. The metal femoral heads M-specification Articul/eze cobalt-
16 6
1j
chromium molybdenum (CoCrMo) alloy femoral heads with a 12/14 (Articul/eze) internal taper, and S-ROM) M-Specification cobalt-chromium molybdenum (CoCrMo) alloy femoral heads with a 11/13 internal taper. As there are no separate shell/liner components to the ASR system, the requested comparison of the shell/liner assembly/disassembly forces and the shell/liner locking mechanism is not applicable.
4. b)
Precliinical and clinical data addressing concerns associated with wear and fixation due to the presence of HA couting or HA particulates and debris.
Response 4 b) Given the crystalline nature of the HA coating and the strength of attachment to the porous surface, we do not feel there is a well-developed mechanism of particulate release from the shell OD into the periarticular tissue or synovial fluid to subsequently migrate into the articular surface. DePuy is not aware of this phenomenon occurring in the clinical setting for HA coated metal-on-metal couples or HA coated metal-onpolyethylene couples. In the situation where an HA particle would potentially be released from the acetabular shell and migrate into the articular region, it would likely be very small in order to advance into the metal-on-metal articular space (less than (b) (4) , for ASR articular surfaces). The potential exists for the smatler particle to pass through the articular region, neither imbedding nor scratching the articular surfaces. Alternatively, if the particle were larger than the clearance between the articular surfaces maintained by the fluid film lubrication regime and became trapped within the articular surfaces under the circumstances of microseparation, we believe that several things would occur:
-
The very hard surfaces of the CoCrMo alloy would crush the weaker and brittle HA particle creating much smaller sub-micron size particles allowing them to float freely out of the surface and become resorbed by the body fluids. If a larger HA particle were to scratch the articular surface, we believe it would be fractured and washed free of the articular surfaces and the scratch would eventually repolish as metal-on-metal heads are known to do.
From the known clinical experience and laboratory testing we do not believe that these particles would cause degradation to the surface of the two hard, metal surfaces.
ct1
17
Exhibit 1
(b) (4)
Test Report
18
(b) (4)
Confidential internal report DePuy, Warsaw

(b) (4)
0000019
............5
...
.............8 ............9
......0...........
......... ..............14
0000020
Confidential internal report
Page 17
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0000035

K040627, Depuy Orthopaedic, ASR Modular Ace Tabular Cup System

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510K SUMMARY - 5 pages

ORIGINAL - 246 pages

REVIEWER INFORMATION - 100 pages

SUPPLEMENT - 129 pages

DePuy Orthopaedics, Inc. PO Box 988

TRADE NAME: COMMON NAME: CLASSIFICATION:

DEVICE PRODUCT CODE: SUBSTANTIALLY EQUIVALENT DEVICES:

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Indications for Use

DePuy ASR TM Modular Acetabular Cup

700 ORTI4CPAEDIC DRIVE WARSAW IN a4si1ogaa

UcPu 1 Orthopaedics, Inc. Q0 i0" ~1~

Tei: 4-1(.574) 267 8143

Dear Ms. Frank: to the

510(k) CONTACT: TRADE NAME: COMMON NAME: CLASSIFICATION:

DEVICE PRODUCT CODE: SUBSTANTIALLY EQUIVALENT DEVICES:

DEVICE DESCRIPTION: metal acetabular

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

April 28, 2009

Food and Drug Administration Rockville MD 20857

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Indications for Use

PageI of 1 (Posted November 13, 2003)

(Division Sgn-O Division of General, Restorative, and Neurological Devices

DEPARTMENT OF HEALTH AND HUA

510(k) Number: K040627

Extended Until: 25-MAY-2005

Based on your recent request, an extension of time has been granted

Natalie'S. Heck Manager, Regulatory Affairs

DEPARTMENT OF HEALTH &HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

a. In Supplement 1, you referenced a previously submitted (b) (4)

Page 2 - Ms. Natalie Heck b. provided in Supplement 1 range from

Page 3 - Ms. Natalie Heck

*fn addition, please recognize that the (b) (4) currently

used in this test report is

Ms. Natalie Heck

a. In Supplement 1, you referenced a previously submitted "(b) (4)

Page 3 - Ms. Natalie Heck

*In addition, please recognize that the (b) (4)

used in this test report is

ut:rA1IMENT OF HEALTH AND HUMAN SERVICES

443-6597, or at its Internet address http://www.fda. gov/cdrh/industr,//support/index.html.

DEPARTMENT OF HEALTh AND HUMAN

Document Mail Center (ffFZ-401)

DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. BOX 988

510(k) Number: K040627

Based on your recent request, an extension of time has been granted

Aug 31, 2004

9200 Corporate Blvd.

a S Manager Heck Manager,. Regulatory Affairs

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

Food and Drug Administration Center for Devices and

July 30, 2004

~ ~ FOOD~ ANDDUYDIITAINMENT iDENTIFICATION NUMBER:

700 Orthopaedic Drive Indiana 46581 -0988 ~~~Warsaw, USA