TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870

K041595 · Biopro, Inc. · KWD · Nov 12, 2004 · Orthopedic

Device Facts

• Record ID: K041595
• Device Name: TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
• Applicant: Biopro, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Nov 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A ) A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot. B) Degenerative arthritis C) Rheumetoid arthritis D) Bunion deformity associated with arthritis of the metatarsal-phalangeal joint E) The titanium version is available for use only in patients susceptible to nickel chromium allergies.

Device Story

BioPro Hemi MP Joint is a press-fit implant designed for the metatarso-phalangeal joint. It replaces damaged joint surfaces to address arthritic degradation, pain, and limited mobility. Available in titanium for patients with nickel-chromium allergies. Used by orthopedic surgeons in clinical settings to restore forefoot ambulatory function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Press-fit implant for metatarso-phalangeal joint. Materials include titanium (for nickel-chromium allergy patients).

Indications for Use

Indicated for patients with arthritic degradation of the metatarso-phalangeal joint, including degenerative arthritis, rheumatoid arthritis, and bunion deformity associated with arthritis, resulting in disabling pain, limited motion, and loss of forefoot ambulatory function. Titanium version indicated for patients with nickel-chromium allergies.

Regulatory Classification

Identification

A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is printed in black and white.

NOV 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

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

Re: K041595

Trade/Device Name: BioPro Hemi MP Joint Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: September 7, 2004 Received: September 9, 2004

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 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 - Mr. David Mrak

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/dsma/dsmamain.html

Sincerely vours.

sincerely yours,

Mark A. Millerson

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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## Indications for Use

510k Number (if known):

Device Name: Biopro Hemi MP Joint

Indications for Use:

- A ) A press fit implant for arthritic degradation of the metatarso-phalangeal joint that has resulted in disabling pain, limited motion and loss of the normal ambulatory function of the forefoot.
- B) Degenerative arthritis
- C) Rheumetoid arthritis
- D) Bunion deformity associated with arthritis of the metatarsal-phalangeal joint
- E) The titanium version is available for use only in patients susceptible to nickel chromium allergies.

Prescription Use ✗ AND/OR
21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use (Part

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

Concurrence of CDRH, Office of Device Evaluation (ODE

evice Evaluation (ODE)
Mark A Millerson

. Restorative, Division of Ge and Neur

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K041595

510(k) Numbe