NELSON RESURFACING HEAD

K983452 · Biomet, Inc. · KXA · Dec 3, 1998 · Orthopedic

Device Facts

• Record ID: K983452
• Device Name: NELSON RESURFACING HEAD
• Applicant: Biomet, Inc.
• Product Code: KXA · Orthopedic
• Decision Date: Dec 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nelson Resurfacing Head is indicated for use in: - a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis - b.) rheumatoid arthritis The Nelson Resurfaced Heads are intended for cemented application and for single use implantation.

Device Story

Nelson Resurfacing Head is a metallic femoral resurfacing prosthesis; designed to preserve natural femur and acetabulum; provides new articulating surface for hip joint. Device manufactured from cobalt-chrome-molybdenum; intended for cemented application; single-use only. Used in orthopedic surgery to treat significant osteonecrosis of femoral head; avoids violation of femoral canal with prosthetic stem. Surgeon implants device to restore joint function; benefits patient by treating diseased portion of joint while maintaining natural bone structure.

Technological Characteristics

Material: Cobalt-chrome-molybdenum alloy. Design: Femoral head resurfacing prosthesis. Application: Cemented. Single-use. No electronic or software components.

Indications for Use

Indicated for patients with non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis) or rheumatoid arthritis requiring 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

• Wright Medical's Converse
• BIOPRO's Ceramic TARA Femoral Resurfacing Component
• THARIES

Submission Summary (Full Text)

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K983452

## SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR:

Biomet. Inc. P. O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587

CONTACT PERSON: Julie K Ryan

Nelson Resurfacing Head DEVICE:

CLASSIFICATION NAME: Hip joint femoral (hemi-hip) metallic resurfacing prosthesis. 888.3400

INTENDED USE: The Nelson Resurfacing Head is indicated for use in:

- a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b.) rheumatoid arthritis

The Nelson Resurfaced Heads are intended for cemented application and for single use implantation.

DEVICE DESCRIPTION: This device is design to save the natural femur and provide a new surface on the femoral head for the hip to pivot on. The natural acetabulum will remain intact. The device will be manufactured out of cobalt-chrome-molybdenum. This device is intended for use with those who have had significant osteonecrosis of the femoral head. This procedure is limited to treating the diseased portion of the joint without violating the femoral canal with the stem of prosthesis.

POTENTIAL RISKS: The potential risk associated with this device is the same as with any joint resurfacing device. These include but are not limited to:

Fracture of the component Cardiovascular disorders Implant loosening /migration Soft tissue imbalance Deformity of the joint Tissue growth failure Delayed wound healing Metal sensitivity

Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Dislocation

SUBSTANTIAL EQUIVALENCE: The Nelson Resurfacing Head is substantially equivalent to most head replacement devices on the market in overall function and design. Predicate devices are Wright Medical's Converse and BIOPRO's Ceramic TARA Femoral Resurfacing Component and THARIES.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 3 1998

Ms. Mary Verstynen Regulatory Affairs Biomet, Inc. Airport Industrial Park P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K983452 Nelson Resurfacing Head Requlatory Class: İI Product Code: KXA Dated: September 28, 1998 Received: September 30, 1998

Dear Ms. Verstynen:

We have reviewed your Section 510(k) 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

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## Page 2 - Ms. Mary Verstynen

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.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Dorico Faluation

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(K) NUMBER IF KNOWN: DEVICE NAME: The Nelson Resurfacing Head

The indications for use are:

- a.) non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
- b.) rheumatoid arthritis

The Nelson Resurfacing Head is cemented femoral component and is a single use implant.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Division Sign-Off
or Over the Counter-Use
(Optional Optional Format 1-2-96)

Division of General Restorative Devices 510(k) Number

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