PRESS-FIT HEAD RESURFACING DEVICE

K023188 · Biomet Orthopedics, Inc. · KXA · Dec 11, 2002 · Orthopedic

Device Facts

• Record ID: K023188
• Device Name: PRESS-FIT HEAD RESURFACING DEVICE
• Applicant: Biomet Orthopedics, Inc.
• Product Code: KXA · Orthopedic
• Decision Date: Dec 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

Device Story

Press-Fit Head Resurfacing Device; metallic hemi-hip prosthesis; replaces outer surface of femoral head while preserving natural bone; articulates against natural acetabulum. Device features cobalt alloy (Co-Cr-Mo) construction; highly polished outer surface; titanium plasma spray coated inner surface; central post for stabilization. Available in 38mm to 60mm diameters (1mm increments). Implanted by orthopedic surgeons; intended for press-fit application. Benefits include preservation of natural femoral head diameter and bone stock.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Cobalt alloy (Co-Cr-Mo) per ASTM F-75; titanium plasma spray coating on inner surface; central post for stabilization; 38-60mm diameter range; metallic hemi-hip resurfacing prosthesis.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease, including osteoarthritis, avascular necrosis, and rheumatoid arthritis requiring hemi-hip femoral head resurfacing.

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

• Cemented Femoral Head Resurfacing Device (K021799)
• Conserve Head (K811008)
• TARA Head (K962514)
• Surface Replacement Hip Prostheses (K811718)

Submission Summary (Full Text)

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KQ2388
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## Summary of Safety and Effectiveness

| Applicant/Sponsor: | Biomet Orthopedics, Inc. |
|--------------------|----------------------------|
| | P.O. Box 587 |
| | Warsaw, Indiana 46581-0587 |

DEC 1 1 2002

- Contact Person: Patricia Sandborn Beres Senior Requlatory Specialist Phone: [phone] Fax: [phone]
Trade Name: Press-Fit Head Resurfacing Device

Common Name: Hemi-hip

Classification Name: Hip joint femoral (hemi-hip) metallic resurfacinq prosthesis (21 CFR 888.3400)

Legally Marketed Device to which Substantial Equivalence is claimed: Cemented Femoral Head Resurfacing Device (K021799), Conserve Head (K811008), TARA Head (K962514), Surface Replacement Hip Prostheses (K811718)

Device Description: The Press-Fit Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip).

The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a titanium plasma spray coated inner surface. A central post is provided for stabilization. The device is available in diameters of 38mm to 60mm, in one-millimeter increments.

Intended Use: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

Summary of Technologies: The materials, surface finishes and processing of the Press-Fit Head Resurfacing Device are similar to the predicate device.

Non-Clinical and Clinical Testing: None provided

MAILING ADDRESS Warsaw, IN 46581-0587 SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 574.267.6639

FAX [phone]

E-MAIL
[e-mail]

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 11 2002.

Ms. Patricia Sandborn Beres Senior Regulatory Affairs Specialist Biomet, Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K023188

Trade Name: Press-Fit Head Resurfacing Device Regulation Number: 21 CFR 888.3400 Regulation Name: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis Regulatory Class: II Product Code: KXA Dated: September 23, 2002 Received: September 24, 2002

Dear Ms. Sandborn Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially 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 (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 svstems (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.

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Page 2 - Ms. Patricia Sandborn Beres

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

l Math A. Melleman

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): KO3 3183

Press-Fit Head Resurfacing Device Device Name:

Indications For Use:

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis.

The device is a single use implant intended for press-fit application.

for Mark N. Mulkerson

(Division Si Division of General, Fir - : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : and Neurological Dev. 023188 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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