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 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, protrusio 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 DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.

Device Description

The subject of this 510(k) consists of modifications to the Instructions for Use (IFU). The following two contraindications and potential adverse effect have been added to the IFU. DePuy Orthopaedics is making these IFU revisions to comply with a request from Health Canada, as well as to update the contents to reflect current industry practice. These are the only changes to the labeling and IFU; there are no changes to the device design.

AI/ML Overview

This 510(k) submission, K083642, describes modifications to the Instructions for Use (IFU) for the DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners. It is not a submission for a new device requiring performance testing against acceptance criteria. Instead, it focuses on label updates, specifically adding contraindications and a potential adverse effect. Therefore, many of the requested categories related to device performance studies, such as sample sizes, expert qualifications, and ground truth establishment, are not applicable to this particular submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This submission is for labeling modifications to an already cleared device, not for proving the performance of a new device against acceptance criteria. The device's performance was established during the original 510(k) clearances (K062426, K023786, K003523, K002883).

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No new performance testing was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. No new performance testing was conducted. The changes to the IFU were made "to comply with a request from Health Canada, as well as to update the contents to reflect current industry practice," implying an expert consensus based on clinical experience and regulatory guidance rather than a specific study with a defined number of experts for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. No new performance testing was conducted requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is an implantable medical device, not an algorithm.

7. The type of ground truth used:

Not applicable for new device performance. The "ground truth" for the IFU modifications is regulatory compliance and updated clinical understanding/industry practice, as prompted by Health Canada and general industry evolution.

8. The sample size for the training set:

Not applicable. As this is not an algorithm, there is no training set. The clinical experience and scientific understanding that led to the IFU changes would be based on a broad range of data from previously implanted devices, post-market surveillance, and general medical literature regarding metal-on-metal implants.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the 510(k) Submission:

This 510(k) submission (K083642) by DePuy Orthopaedics, Inc. is a submission for labeling changes only for their DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners. The changes involve adding two contraindications and one potential adverse effect to the Instructions for Use (IFU). These revisions were made to comply with a request from Health Canada and to reflect current industry practice. No changes to the device design, indications for use, or intended use were made. The FDA determined the device, with its updated labeling, to be substantially equivalent to previously legally marketed predicate devices, allowing its continued marketing.

Summary

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K083642 (pg 1/2)

MAR 6 2009

510 (k) Summary (As required by 21 CFR 807.92 and 21 CFR 807.93)

NAME OF SPONSOR:

510(K) CONTACT:

DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46582 Establishment Registration Number: 1818910

Dawn Sinclair Regulatory Affairs Associate Telephone: (574) 372-5023 Facsimile: (574) 371-4987 Electronic Mail: Dsincla3@its.jnj.com

DATE PREPARED:

PROPRIETARY NAME:

COMMON NAME:

CLASSIFICATION:

December 5, 2008

87 KWA

DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners

Acetabular Cup Prosthesis

Class III per 21 CFR 888.3330, Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis

DEVICE PRODUCT CODE:

SUBSTANTIALLY EQUIVALENT DEVICE(S):

DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K062426 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K023786 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K003523 DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners, K002883 Biomet® Metal-on-Metal Hip Systems, K082446

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K083642.(pg 2/2)

DESCRIPTION:

Contraindications:

Use is contraindicated in cases with chronic renal failure. .
Females of childbearing age are contraindicated due to the unknown effects of . elevated levels of metal ions on the fetus.

Potential adverse effect:

The potential long-term biological effects of metal wear debris and metal ion . production are not known.
No changes have been made to the Indications for Use or the Intended Use of this device.

INDICATIONS AND INTENDED USE:

Indications:

Intended Use:

The Pinnacle Metal-on-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc. % Ms. Dawn Sinclair Regulatory Associate, Regulatory Affairs 700 Orthopaedic Dr. Warsaw, Indiana 46581

MAR 6 2009

Re: K083642

Trade/Device Name: DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint, metal/metal semi-constrained, with an uncemented acctabular component, prosthesis Regulatory Class: III Product Code: KWA Dated: December 8, 2008

Dear Ms. Sinclair:

Received: December 9, 2008

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

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Page 2 - Ms. Dawn Sinclair

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.

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 to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510 (k) Number (if known): 16083642 (po 1/1)

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 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, protrusio acetabuli, silipped 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 DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

() x Sh Yo

(Please do not write below this line. Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

CDRH, Office of Device Evaluation (ODE)

Mark H. Milliken

Page 1 of 1

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

0000

510(k) Number

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.