OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM

K060536 · Osteomed LP · KWD · Jun 2, 2006 · Orthopedic

Device Facts

• Record ID: K060536
• Device Name: OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
• Applicant: Osteomed LP
• Product Code: KWD · Orthopedic
• Decision Date: Jun 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful metatarsophalangeal joint. OsteoMed 1st MPJ Hemi Implants are intended for single use only.

Device Story

The OsteoMed 1st MPJ Hemi Implant is a single-piece orthopedic prosthesis designed for first metatarsal phalangeal joint arthroplasty. It replaces the distal base of the proximal phalanx to provide a smooth articular surface against the first metatarsal head. The device is implanted by a surgeon via a press-fit bone-implant interface. It is available in multiple sizes to match patient anatomy. The implant serves to restore joint function and alleviate pain in patients suffering from inflammatory arthritis or degenerative conditions like hallux valgus and hallux rigidus. It is intended for single use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and technological similarities to legally marketed predicate devices.

Technological Characteristics

One-piece hemi-toe prosthesis; materials: cobalt chromium (ASTM F-799) with optional titanium plasma-coated stem; fixation: press-fit; form factor: multiple sizes corresponding to distal base of proximal phalanx anatomy.

Indications for Use

Indicated for patients with inflammatory arthritis of the first metatarsal joint, hallux valgus, hallux rigidus, or unstable/painful metatarsophalangeal joint, provided there is good bone stock and integrity of the first metatarsal head.

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.

Predicate Devices

• BioPro Hemi MP Joint (K041555)
• Kinetikos Medical, K2 Hemi Toe Implant System (K023770)
• Fi; tira BioMedical Metal Hemi Toe Implant (K971047)

Submission Summary (Full Text)

{0}------------------------------------------------

K060536 F

Image /page/0/Picture/1 description: The image shows a date, "JUN - 2 2006". The month is June, the day is the 2nd, and the year is 2006. The text is in a bold, sans-serif font.

## 510(k) Summary

Device Proprietary Name:

Device Common Name:

Classification Name:

Name of Submitter:

OsteoMed 1st MPJ Hemi Implant System

Hemi Toe Implant

KWD Prosthesis, Toe, Hemi, Phalangeal

OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: [phone] Fax: [phone]

Contact Person:

Dawn D. Tindall

Date Prepared:

May 9, 2006

Summary:

The OsteoMed 1st MPJ Hemi Implant is a one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the distal base of the proximal phalanx and provide a smooth articular surface for the adjacent first metatarsal head. It is available in several sizes in direct per portion to the anatomic construct of the distal base of the proximal phalanx. Primary fixation is intended via a press fit bone implant interface. The OsteoMed 1* MPJ Hemi Implant is made of cobalt chromium (ASTM F-799) and may also be provided with a titanium plasma coated stem.

The OsteoMed 186 MPJ Hemi Implant System is indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions; hallux valgus, hallux rigidus, and an unstable or painful metatarsophiangeal joint. OsteoMed 18 MPJ Hemi Implants are intelded for single use only.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the BioPro Hemi MP Joint (K041555), the Kinetikos Medical, K2 Hemi Toe Implant System (K023770) and the Fi; tira BioMedical Metal Hemi Toe Implant (K971047).

Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the OsteoMed 1ª MPJ Hemi Implant System does not roisoned new safety or effectiveness issues.

Image /page/0/Picture/21 description: The image shows the logo for Colson Associates. The logo consists of the word "Colson" inside of a circle, with a vertical line extending from the top of the circle. To the right of the circle is the text "A COLSON ASSOCIATE".

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an emblem of a stylized caduceus, a symbol often associated with medicine and health care. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the emblem. The emblem is a simple, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 2006

Ms. Dawn D. Tindall Regulatory Affairs OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001

K060536 Re:

> Trade/Device Name: 1st MPJ Hemi Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Class II Product Code: K WD Dated: May 10, 2006 Received: May 11, 2006

Dear Ms. Tindall:

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

{2}------------------------------------------------

Page 2 - Ms. Dawn D. Tindall

forth in the quality systems (OS) 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 vou 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. Melkerson, M.S.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use

510(k) Number (if known): KO(0.536

Device Name:

Indications for Use:

Indicated for use in the treatment of patients with inflammatory arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head, along with the following clinical conditions: hallux valgus, hallux rigidus and an unstable or painful metatarsophalangeal joint. OsteoMed 1st MPJ Hemi Implants are intended for single use only.

Prescription Use X (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 OF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
| <img alt="signature" src="signature.png"/> |

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

(Posted November 13,

(Posted November 13, 2400k) Number__ K060536

Page _1_of_1_