CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY

K063370 · Arthrosurface, Inc. · KWD · Jan 12, 2007 · Orthopedic

Device Facts

• Record ID: K063370
• Device Name: CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY
• Applicant: Arthrosurface, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Jan 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

Device Story

Contoured Articular Prosthetic (CAP) 7.0mm MTP Resurfacing Hemi-arthroplasty is a single-use orthopedic implant; designed for metatarsophalangeal (MTP) joint resurfacing. Device functions as a hemi-arthroplasty component; requires bone cement for fixation. Used by orthopedic surgeons in clinical settings to treat arthritis and joint instability. Provides a reduced-size alternative to the 8.0mm Taper Post predicate; maintains identical design and material characteristics. Benefits patients by restoring joint surface integrity and reducing pain associated with degenerative or post-traumatic conditions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarity to the predicate device.

Technological Characteristics

Hemi-arthroplasty implant for MTP joint; reduced length and diameter version of 8.0mm Taper Post. Single-use; requires bone cement. No software or electronic components.

Indications for Use

Indicated for patients with degenerative or post-traumatic arthritis of the metatarsophalangeal (MTP) joint with good bone stock, including hallux valgus, hallux limitus, hallux rigidus, and unstable or painful MTP joints.

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

• Toe joint phalangeal (hemi-toe) polymer prosthesis (K031859)

Submission Summary (Full Text)

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K063370 p qe 'f²

| 510(k) Owner: | Arthrosurface, Inc.<br>28 Forge Parkway<br>Franklin, MA 02038 |
|---------------|---------------------------------------------------------------|
| Tel: | 508.520.3003 |
| Fax: | 508.528.4604 |

JAN 12 2007

| Contact: | Dawn Wilson<br>Director, Quality Systems |
|----------------------------|-----------------------------------------------------------------------------------|
| Date of Preparation: | October 18, 2006 |
| Trade Name: | Contoured Articular Prosthetic (CAP) ™<br>7.0mm MTP Resurfacing Hemi-arthroplasty |
| Common Name: | 7.0mm MTP Resurfacing Prosthesis |
| Device: | Prosthesis, Toe, Hemi-, Phalangeal |
| Classification Regulation: | Regulation Number 888.3730 |
| Device Class: | Class II |
| Review Panel: | Orthopedic |
| Product Code: | KWD |

## Device Intended Use

Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

# Device Description

The 7.0mm MTP Taper Post is a reduced length and diameter version of the sponsor's previously cleared and commercially marketed 8.0mm Taper Post, but is otherwise identical.

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## Substantial Equivalency:

The intended use, materials, design features and application of the Proposed Device are substantially equivalent to the sponsor's previously cleared and commercially marketed device (K031859 Toe joint phalangeal (hemi-toe) polymer prosthesis, Arthrosurface, Inc.).

The fundamental scientific technology of the proposed device has not changed relative 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle-like bird with three stylized stripes forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrosurface, Inc. % Ms. Dawn Wilson Director, Quality Systems 28 Forge Parkway Franklin, Massachusetts 02038

JAN 1 2 2007

Re: K063370

Trade/Device Name: Contoured Articular Prosthetic CAP™ 7.0mm MTP Resurfacing Hemi-arthroplasty Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: November 2, 2006 Received: November 13, 2006

Dear Ms. Wilson:

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 udications for use stated in the enclosure) to legally marketed predicate devices marketed in internate 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 Fedral Food, Or us, 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 misbaandijng 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, TDA 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 proctice 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. Dawn Wilson

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,

Barbara fuchund

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

Enclosure

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510(k) Number (if known): _ Kob 3370

Device Name:

Contoured Articular Prosithetic (CAP) ™ 7.0mm MTP Resurfacing Hemi-arthroplasty

### Indications for Use:

Hemi-arthroplasty implant for the metatarsophalangeal joint for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.

Prescription Use X Over-The-Counter Use Prescription Ose -------------------------------------------------------------------------------------------------------------------------------------------------------------(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)

Barbara Brichum

Division of General, Restorative, and Neurological Devices

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510(k) Number K063370 000013