FINGER JOINT PROSTHESIS

K013629 · Avanta Orthopaedics, Inc. · KYJ · Jan 25, 2002 · Orthopedic

Device Facts

• Record ID: K013629
• Device Name: FINGER JOINT PROSTHESIS
• Applicant: Avanta Orthopaedics, Inc.
• Product Code: KYJ · Orthopedic
• Decision Date: Jan 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3230
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.

Device Story

Finger joint prosthesis designed for replacement of damaged Metacarpophalangeal (MCP) joints. Implant consists of silicone polymer; features stems for placement into the intramedullary canal of the metacarpal and proximal phalanx. Device is constrained; intended for single use; surgically implanted for duration exceeding 30 days. Provides structural replacement for arthritic joints to restore function. Used by orthopedic surgeons in clinical/surgical settings.

Clinical Evidence

Bench testing only. Flexion testing performed to demonstrate mechanical equivalence to the predicate device.

Technological Characteristics

Silicone polymer implant; constrained design; 7 available sizes; intramedullary canal fixation; single-use; non-sterile status not specified but implies standard surgical implantation.

Indications for Use

Indicated for patients requiring replacement of the Metacarpophalangeal (MCP) joint of the hand due to rheumatoid, osteoarthritis, or post-traumatic arthritis.

Regulatory Classification

Identification

A finger joint polymer constrained prosthesis is a device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint. This generic type of device includes prostheses that consist of a single flexible across-the-joint component made from either a silicone elastomer or a combination pf polypropylene and polyester material. The flexible across-the-joint component may be covered with a silicone rubber sleeve.

Predicate Devices

• Sutter Finger Joint Prosthesis (K870200)

Submission Summary (Full Text)

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## 510 (k) Summary

## JAN 2 5 2002

Page 1 of 2

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

January 16, 2001 Prepared:

Avanta Orthopaedics, Inc. Applicant: 9369 Carroll Park Drive, Suite A San Diego, CA 92121

858-452-8580 Telephone: [phone] Fax: Louise M. Focht Contact:

Prosthesis, Finger, Constrained, Polymer Device Name: Finger Joint Prosthesis Device Trade Name: Class II Device Classification: Orthopedic Reviewing Panel: 888.3230 Regulation Number 87 KYJ Product Code: Sutter Finger Joint Sutter Prosthesis Predicate Device: Corporation (K870200). 2030506 Registration Number: 9001389 Owner Operator Number:

Device Description:

The finger joint prosthesis like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the MCP joint of the hand.

Indications for Use:

Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.

Comparison to Predicate Device:

The legally marketed predicate device to which this device is substantially equivalent is the Sutter Finger Joint Prosthesis.

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page 2 of 2

Regulatory Class: II 87 KYJ Product Code:

| Item | Avanta Product | Sutter Biomedical |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Finger Joint Prosthesis | Sutter Finger Joint Prosthesis |
| Use | Single use | Single use |
| Fixation | None | None |
| Constraint | Constrained | Constrained |
| Material | Silicone. | Silicone |
| Sizes | 7 sizes | 7 sizes |
| Indications for use | Avanta Orthopaedics Finger Joint<br>Prosthesis is intended for replacement<br>of the Metacarpophalangeal joint of the<br>hand which has been damaged by<br>rheumatoid, osteo or post traumatic<br>arthritis. | Sutter Finger Joint Prosthesis is<br>intended for replacement of the<br>Metacarpophalangeal joint of the hand<br>which has been damaged by<br>rheumatoid, osteo or post traumatic<br>arthritis. |
| Item | Avanta Product | Sutter Biomedical |
| Product Name | Finger Joint Prosthesis | Sutter Finger Joint Prosthesis |
| Use | Single use | Single use |
| Fixation | stem in intramedulary canal | stem in intramedulary canal |

Similarities of the Avanta Orthopaedics Finger Joint Prosthesis and the Sutter Finger Joint Prosthesis 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 metacarpal and the proximal phalanx;

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.

Flexion testing was performed on the Avanta Product to demonstrate substantial equivalence to the predicate device.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 2 5 2002

Re: K013629

Trade/Device Name: Finger Joint Prosthesis Regulation Number: 21 CFR 888.3230 Regulation Name: Finger Joint Polymer Constrained Prosthesis Regulatory Class: Class II Product Code: KYJ Dated: November 2, 2001 Received: November 5, 2001

Dear Ms. Focht:

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. Louise Focht

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 vours.

Sincerely yours,

Mark N Mulkersm

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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Page 1 of _ 1 .

510 (k) Number (If Known): Koi3629

Finger Joint Prosthesis Device Name:

## Indications for Use:

Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.

Mark n Milliken

rative

510(k) Number -

(Division Sign-Off)

510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

013629

Prescription Use (Per 21 CFR § 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)