PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS

K002883 · DePuy Orthopaedics, Inc. · KWA · Oct 13, 2000 · Orthopedic

Device Facts

• Record ID: K002883
• Device Name: PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: KWA · Orthopedic
• Decision Date: Oct 13, 2000
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3330
• Device Class: Class 3
• Attributes: Therapeutic

Intended 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 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 28mm diameter Co-Cr-Mo femoral heads only.

Device Story

Metal acetabular cup liner; 28mm inner diameter; neutral style. Mechanically locked into Pinnacle Acetabular Shells via taper junction; articulates with 28mm Co-Cr-Mo femoral heads. Used in total hip replacement surgery; performed by orthopedic surgeons in clinical/hospital settings. Provides bearing surface for hip joint reconstruction; restores joint function; alleviates pain from structural hip damage.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to the predicate device.

Technological Characteristics

Material: Co-Cr-Mo alloy. Form factor: 28mm inner diameter metal liner. Interface: Taper junction locking mechanism for Pinnacle Acetabular Shells. Energy source: None (mechanical).

Indications for Use

Indicated for total hip replacement in patients with severe hip pain/disability due to rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, femoral fracture non-union, congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, or previous fusion with inadequate bone stock.

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 Ultima Metal-On-Metal Acetabular Cup

Submission Summary (Full Text)

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### 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: | Cheryl Hastings<br>Director, Regulatory Affairs |
| TRADE NAME: | DePuy Pinnacle Metal-On-Metal Acetabular Cup<br>Liners |
| COMMON NAME: | Acetabular Cup Prosthesis |
| CLASSIFICATION: | 888.3330 Hip joint metal/metal semi-constrained, with<br>an uncemented acetabular component, prosthesis |
| DEVICE PRODUCT CODE: | 87 JDM |
| SUBSTANTIALLY EQUIVALENT DEVICES: | 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, osteoarthritis, 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, 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 Limers are intended for use with DePuy 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.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, representing the department's focus on people and health.

#### Public Health Service

# OCT 1 3 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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 we have hove have determined the device is substantially equivalent (for the indications for use above and 10 and 10 and 11 interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in encordance 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. The general control 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 (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, Parts 800 to 895. 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.

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## Page 2 - Ms. Cheryl K. Hastings

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and II you desire specific actice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for mi This anaguestions on the promotion and advertising of your device, [phone]. Tructionally, for quest at [phone]. Also, please note the factory of prease contact the Office or Compilance an (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your responsibilities and more [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neik.P.D. for

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

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510(k) Number (if known) KU02883

Device Name DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners

### Indications for Use:

Indications for Use:
The Pinnacle Metal-On-Metal Acetabular Cup Liners are indicated for use as the acti The Pinnacle Metal-On-Metal Acclaidian Cap Patients suffering severe pain and component in total lilip replacement procession the mossio, and non union of femora disability due to structural damage in the ling Jour non non-union of femoral
post-traumatic arthritis, collagen disorders, avascular necrosis, and non-unital hindysplasja, post-fraumatic artimus, collaged undicated for patents with congenital hip dysplasia,
fractures. Use of the prosthesis is also indicated for parents his are to previous fivio fractures. Use of the prosulesis is also marcal epiphysis and disability due to previous fusion, prom asto acentibut, shpped capital read.
where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Metal-On-Metal Acetabular Cup Liners are intended for use with DePuy I he Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.

Nilo Aricma

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(Division Sign-Off) Division of General Restorative Devices 1002883 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The Counter Use

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