ULNAR HEAD IMPLANT

K982268 · Avanta Orthopaedics, Inc. · KXE · Dec 4, 1998 · Orthopedic

Device Facts

• Record ID: K982268
• Device Name: ULNAR HEAD IMPLANT
• Applicant: Avanta Orthopaedics, Inc.
• Product Code: KXE · Orthopedic
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Avanta Orthopaedics Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty: - Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic disabilities presenting the following: - Pain and weakness of the wrist joint not improved by conservative treatment - Instability of the ulnar head with x-ray evidence of dorsal subluxation and erosive changes - Failed ulnar head resection

Device Story

Ulnar head implant designed for surgical replacement of distal ulnar head; intended for patients with rheumatoid, degenerative, or post-traumatic wrist disabilities. Device consists of prosthetic implant placed into intramedullary canal of distal ulna; functions as non-constrained replacement for distal radioulnar joint. Used by orthopedic surgeons in clinical/surgical settings. Provides structural replacement to restore joint function; alleviates pain and instability associated with ulnar head pathology. Benefits patient by addressing failed prior resections or chronic joint degeneration.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design characteristics, intended use, and material safety comparisons.

Technological Characteristics

Prosthetic ulnar head implant; Co-Cr construction; intramedullary stem fixation; non-constrained design; single-use; sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring distal radioulnar joint replacement following ulnar head resection arthroplasty due to rheumatoid, degenerative, or post-traumatic disabilities. Includes patients with wrist pain/weakness unresponsive to conservative treatment, ulnar head instability with radiographic dorsal subluxation/erosive changes, or failed prior ulnar head resection.

Regulatory Classification

Identification

A wrist joint ulnar (hemi-wrist) polymer prosthesis is a mushroom-shaped device made of a medical grade silicone elastomer or ultra-high molecular weight polyethylene intended to be implanted into the intramedullary canal of the bone and held in place by a suture. Its purpose is to cover the resected end of the distal ulna to control bone overgrowth and to provide an articular surface for the radius and carpus.

Predicate Devices

• Silastic Swanson Ulnar Head Implant (Dow Corning Corporation/Wright Medical)

Submission Summary (Full Text)

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DEC 4 1998

Image /page/0/Picture/1 description: The image shows the logo for Avanta Orthopaedics. The logo is in black and white and features the word "AVANTA" in large, bold letters. Below the word "AVANTA" is the word "ORTHOPAEDICS" in smaller letters. Above the logo is the number K982268.

## 510 (k) Summary

Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:

| Prepared: | June 26, 1998 |
|------------|--------------------------------------------------------------------------------------|
| Applicant: | Avanta Orthopaedics, Inc.<br>9369 Carroll Park Drive, Suite A<br>San Diego, CA 92121 |
| Telephone: | 619-452-8580 |
| Fax: | 619-452-9945 |

Hax: Louise M. Focht Contact:

Device Name: Device Trade Name: Device Classification: Reviewing Panel: Regulation Number Product Code: Predicate Device:

Wrist joint ulnar (hemi-wrist) prosthesis Ulnar head implant Class II Orthopedic 888.3810 87 KXE Silastic Swanson Ulnar Head Implant originally by Dow Corning Corporation, then Dow Corning Wright and Wright Medical which has been marketed since 1971. 2030506 9001389

Registration Number: Owner Operator Number:

Device Description:

The ulnar head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the distal ulnar head.

## Indications for Use:

A vanta Orthopaedics Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic ● disabilities presenting the following:
- Pain and weakness of the wrist joint not improved by conservative treatment ●

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- Instability of the ulnar head with x-ray evidence of dorsal subluxation and . erosive changes
- . Failed ulnar head resection

Comparison to Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Dow Corning Corporation Silastic Swanson Ulnar Head Implant.

| Regulatory Class: | II |
|-------------------|--------|
| Product Code: | 87 KXE |

| Item | Avanta Product | Dow Corning/Wright Medical<br>Technologies |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Ulnar Head Implant | Silastic Swanson Ulnar Head Implant |
| Use | Single use | Single use |
| Fixation | stem in intramedullary canal | stem in intramedullary canal |
| Constraint | non constrained | non constrained |
| Material | Co-Cr. | Silicone |
| Sizes | 3 sizes, 1, 2, 3 | 7 sizes 1-7 |
| Indications for use | Avanta Orthopaedics Ulnar Head<br>implant is intended for replacement<br>of the distal radioulnar joint<br>following ulnar head resection<br>arthroplasty: Replacement of the<br>distal ulnar head for rheumatoid,<br>degenerative, or post-traumatic<br>disabilities presenting the following:<br>pain and weakness of the wrist joint<br>not improved by conservative<br>treatment instability of the ulnar<br>head with x-ray evidence of dorsal<br>subluxation and erosive changes<br>failed ulnar head resection | Silastic Swanson Ulnar Head implant<br>is intended for replacement of the<br>distal radioulnar joint following ulnar<br>head resection arthroplasty:<br>Replacement of the distal ulnar head<br>for rheumatoid, degenerative, or post-<br>traumatic disabilities presenting the<br>following: pain and weakness of the<br>wrist joint not improved by<br>conservative treatment instability of<br>the ulnar head with x-ray evidence of<br>dorsal subluxation and erosive<br>changes failed ulnar head resection |

Similarities of the Avanta Orthopaedics Radial Head Implant and the Dow Corning/Wright Medical Technology, Inc. Ulnar Head Implant include;

Both devices are intended for single use only; Both devices are intended for surgical implantation longer than 30 days; Both devices are placed into the intramedullary canal of the distal end of the ulna: Both devices are made of industry standard materials. No new materials are introduced in either product; Both devices are comparably sized; Both devices have the same indications for use.

Summary:

The device and the predicate device have similar design characteristics and intended use. The new device is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 4 1998

Ms. Louise M. Focht Avanta Orthopedics 9369A Carroll Park Drive San Diego, California 92121

· Re: K982268 Ulnar Head Implant Trade Name: Requlatory Class: II Product Code: KXE Dated: September 24, 1998 Received: September 25, 1998

Dear Ms. Focht:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਜੋ 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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.

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## Page 2 - Ms. Louise M. Focht

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 regulation (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 ene organs or compitiled, "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.
Director

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page ***_ of _***

510 (k) Number (If Known): K98226
Device Name: Ulnar Head

## Indications for Use:

Avanta Orthopaedics Ulnar Head implant is intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty:

- Replacement of the distal ulnar head for rheumatoid, degenerative, or post-. traumatic disabilities presenting the following:
- Pain and weakness of the wrist joint not improved by conservative . treatment
- Instability of the ulnar head with x-ray evidence of dorsal subluxation . and erosive changes
- Failed ulnar head resection .

Prescript.ion use Yz

Over the County Use No