MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599

K061089 · Biopro, Inc. · KYI · Jun 20, 2006 · Orthopedic

Device Facts

• Record ID: K061089
• Device Name: MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599
• Applicant: Biopro, Inc.
• Product Code: KYI · Orthopedic
• Decision Date: Jun 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Rheumatoid arthritis 2. Traumatic arthritis 3. Osteoarthritis 4. Post Fracture deformation or bone loss

Device Story

Modular Thumb Implant; orthopedic prosthesis for thumb joint replacement. Used in surgical settings by orthopedic surgeons to address joint degeneration or deformity. Device replaces damaged carpal trapezium joint surfaces to restore function and reduce pain. Implant design allows for modular assembly to accommodate patient anatomy. Clinical benefit includes improved joint mobility and pain relief for patients with arthritis or post-traumatic conditions.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and intended use.

Technological Characteristics

Modular orthopedic prosthesis for wrist joint carpal trapezium. Class II device (21 CFR 888.3770). Product code KYI. Mechanical implant design.

Indications for Use

Indicated for patients with rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post-fracture deformation/bone loss requiring thumb joint replacement.

Regulatory Classification

Identification

A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the eagle in a circular pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 2006

Mr. David Mrak Director of Product Development BioPro, Inc. 17 Seventeenth Street Port Huron, Michigan 48060

Re: K061089

> Trade/Device Name: Modular Thumb Implant Regulation Number: 21 CFR 888.3770 Regulation Name: Wrist joint carpal trapezium polymer prosthesis Regulatory Class: Class II Product Code: KYI Dated: June 15, 2006 Received: June 16, 2006

Dear Mr. Mrak:

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 net

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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. 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark N. Meller, M.S.

ark N. Melkerson, M.S. 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): KO61089

Device Name: Biopro Modular Thumb

Indications For Use:

1. Rheumatoid arthritis

- 2. Traumatic arthritis
- 3. Osteoarthritis
- 4. Post Fracture deformation or bone loss

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulu Lenuw
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

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**510(k) Number** Lo bl089