DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

K062426 · DePuy Orthopaedics, Inc. · KWA · Dec 15, 2006 · Orthopedic

Device Facts

• Record ID: K062426
• Device Name: DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Dec 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The subject Pinnacle Metal-On-Metal Liners are intended to be used with the DePuy Pinnacle metal acetabular shells to resurface the acetabular socket in cementless total hip arthroplasty.

Device Story

Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner; metal liner component for cementless total hip arthroplasty. Device functions as acetabular socket surface; mechanically locked to Pinnacle Acetabular Shell via taper junction; articulates with M-Spec Co-Cr-Mo femoral heads. Modification adds 40mm and 44mm inner diameters and a 36mm liner with 50mm outer diameter. Used in clinical orthopedic settings by surgeons. Provides stable articulation surface for hip joint replacement; restores joint function; reduces pain for patients with severe hip structural damage.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metal acetabular cup liner; Co-Cr-Mo alloy construction; taper junction mechanical locking mechanism; neutral style; sizes include 40mm and 44mm inner diameters. No software or electronic components.

Indications for Use

Indicated 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, non-union of femoral fractures, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion where bone stock is inadequate for other reconstruction techniques. For use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.

Regulatory Classification

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).

Predicate Devices

• DePuy Pinnacle 36mm Metal-On-Metal Acetabular Cup Liners (K003523)
• DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners (K002883)
• DePuy ASR Modular Acetabular Cup System (K040627)

Submission Summary (Full Text)

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K062426

## DEC 1 5 2006

#### SUMMARY OF SAFETY AND EFFECTIVENESS

| NAME OF FIRM: | DePuy Orthopaedics, Inc.<br>P.O. Box 988<br>700 Orthopaedic Drive<br>Warsaw, IN 46581-0988 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Anne M. Schuler<br>Sr. Regulatory Affairs Associate |
| DATE PREPARED: | August 17, 2006 |
| TRADE NAME: | DePuy Pinnacle Metal-on-Metal Acetabular Cup<br>Liners |
| COMMON NAME: | Acetabular Cup Liner |
| CLASSIFICATION: | Hip joint metal/metal semi-constrained with an<br>uncemented acetabular component prosthesis (per 21<br>CFR 888.3330), Class III Device |
| DEVICE PRODUCT CODE: | 87 KWA |
| SUBSTANTIALLY EQUIVALENT<br>DEVICE(S): | DePuy Pinnacle 36mm Metal-On-Metal Acetabular<br>Cup Liners (K003523, cleared December 13, 2000)<br>DePuy Pinnacle Metal-On-Metal Acetabular Cup<br>Liners (K002883, cleared Ocotober 13, 2000)<br>DePuy ASR Modular Acetabular Cup System<br>(K040627, cleared August 5, 2005) |

## DEVICE INFORMATION:

#### A. DEVICE DESCRIPTION

The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner is a metal liner that is intended for use with Pinnacle Acetabular Shells that have been cleared previously. The liners currently are offered with inner diameters (ID) of 28-36mm, this modification is to add 40 and 44mm Ids and to add a 36mm liner with a outer diameter (OD) of 50mm. The liners are offered in a neutral style only. The subject Pinnacle MOM liner is mechanically locked with the shell via a taper junction which is identical to the taper junction used for the cleared 28 and 36mm liners and articulates. with previously cleared M-Spec metal prosthetic femoral heads.

## B. INTENDED USE AND INDICATIONS

#### Intended Use

The subject Pinnacle Metal-On-Metal Liners are intended to be used with the DePuy Pinnacle metal acetabular shells to resurface the acetabular socket in cementless total hip arthroplasty.

* 30 36 20 3 8 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3

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### Indications

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 for to structural damage in the hip joint from rheumatoid arthritis, osteoathinis, post-traumatic athritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congental hip dysplasio acetabuli, slipped capitolicios al 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 DePuyPinnacie Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only

## C. BASIS OF SUBSTANTIAL EQUIVALENCE:

The modified Pinnacle Metal Acetabular Cup Liners have the same intended use, indications, manufacturing method, sterilization and packaging as the Pinnacle 36mm and 28mm Acetabular Liners cleared in K003523 and K002883 and the same intended use and indications as the ASR Modular Cup System cleared in K040627. The designs of the modified Pinnacle Metal Acetabular Cup Liners is similar to the design of the previously cleared Pinnacle Metal-On-Metal liners. The modified liners are offered in ange of sizes (inner and outer diameters) that fall within the range of sizes previously clearn for the ASR Modular Acetabular Cup System. Based on similarities in design, intended usa, indications, manufacturing methods, sterilization and packaging DePuy belineed that the Pinnacle Metal-On-Metal Acetabular Cup Liners are substantially equivalent to the previously cleared Pinnacle 36 and 28mm metal Acetabular Liners.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics Inc. % Ms. Kathy Harris Director of Regulatory Affairs 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

DEC 1 5 2006

Re: K062426

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 acetabular component prosthesis Regulatory Class: Class III Product Code: KWA Dated: December 1, 2006 Received: December 4, 2006

Dear Ms. Harris:

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

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Page 2 - Ms. Kathy Harris

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 (OS) 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 Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sincerely yours,

Mark McMillan

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

510(k) Number (if known): K062426 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 non-union of femoral fractures. Use of the prosthesis is also indicated for pationts with congenital hip dysplasia, protrusio acelabuli, 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 DcPuv Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.

Prescription Use Over-The-Counter Use XX AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Miller

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

510(k) Number K062426