CONSERVE PRESSFIT FEMORAL COMPONENT

K082673 · Wrightmedicaltechnologyinc · KXA · Dec 12, 2008 · Orthopedic

Device Facts

• Record ID: K082673
• Device Name: CONSERVE PRESSFIT FEMORAL COMPONENT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KXA · Orthopedic
• Decision Date: Dec 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia. The CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use

Device Story

The CONSERVE® Pressfit Femoral Resurfacing Component is a metallic hemi-hip resurfacing prosthesis designed for non-cemented fixation. It is manufactured from Cobalt Chrome Alloy and features a plasma-sprayed undersurface to facilitate bone integration. The device is available in 12 sizes with 2mm increments. It is intended for use by orthopedic surgeons in a clinical/surgical setting to address degenerative joint disease. By resurfacing the femoral head, the device aims to reduce pain and restore hip function in skeletally mature patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technological characteristics compared to legally marketed predicate devices.

Technological Characteristics

Material: Cobalt Chrome Alloy. Surface: Plasma spray undersurface. Form factor: Femoral resurfacing component available in 12 sizes (2mm increments). Fixation: Non-cemented (pressfit).

Indications for Use

Indicated for skeletally mature patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, painful hip dysplasia) requiring hemi-hip resurfacing for pain relief or improved function.

Regulatory Classification

Identification

A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.

Predicate Devices

• CONSERVE® Cemented Femoral Component (K062960)
• Biomet Pressfit Head Resurfacing Device (K023188)

Submission Summary (Full Text)

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K082673

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## DEC 1 2 2008

### 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 CONSERVE® Pressfit Femoral Resurfacing Component.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|--------------------------------------------------------------------------------------------|
| Date: | September 12, 2008 |
| Contact Person: | Theresa Leister |
| | Senior Regulatory Affairs Specialist |
| Proprietary Name: | CONSERVE® Pressfit Femoral Resurfacing<br>Component |
| Common Name: | Femoral Resurfacing Component |
| Classification Name and Reference: | 21 CFR 888.3400 Hip joint femoral (hemi-hip)<br>metallic resurfacing prosthesis – Class II |
| Device Product Code and Panel Code: | Orthopedics/87/ KXA |

#### DEVICE INFORMATION

#### A. INTENDED USE

-

The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

The CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use

### B. DEVICE DESCRIPTION

The design features of the CONSERVE® Femoral Resurfacing Component are summarized below:

- . Manufactured from Cobalt Chrome Alloy
- 12 Sizes in 2mm increments .
- . Plasma Spray undersurface

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082673

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### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use, design, and material of the CONSERVE® Pressfit Femoral Resurfacing Component are substantially equivalent to the CONSERVE® Cemented Femoral Component (K062960) and the Biomet Pressfit Head Resurfacing Device (K023188). The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the CONSERVE® Pressfit Femoral Resurfacing Component are adequately supported by the substantial equivalence information and materials information provided within this Premarket Notification.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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DEC 1 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Ms. Theresa Leister Senior Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K082673

Trade/Device Name: CONSERVE® Pressfit Femoral Resurfacing Component Regulation Number: 21 CFR 888. 3400 Regulation Name: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis Regulatory Class: II Product Code: KXA Dated: September 12, 2008 Received: September 15, 2008

Dear Ms. Leister:

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.

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Page 2 - Ms. Theresa Leister

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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millerson

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):

Device Name: _CONSERVE® Pressfit Femoral Resurfacing Component

Indications For Use:

The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia.

CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millman

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

**510(k) Number** K082673

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