ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS

K063058 · Arthrex, Inc. · KWD · Jan 3, 2007 · Orthopedic

Device Facts

• Record ID: K063058
• Device Name: ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
• Applicant: Arthrex, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Jan 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex AnaToemic™ Phalangeal Prosthesis is a press-fit implant that is intended to be used in patients with hallux limitus, hallux rigidus, hallux valgus, arthritic degradation of the metatarso-phalangeal joint, degenerative arthritis, rheumatoid arthritis, and bunion deformity associated with arthritis of the metatarsal-phalangeal joint.

Device Story

One-piece hemi-arthroplasty implant for metatarso-phalangeal joint of big toe; replaces distal articular surface. Design features: polished concave oval disk; rough stem with barbed trapezoid shape and lozenge cross-section. Implanted via press-fit technique. Intended to address arthritic conditions and deformities of the big toe joint. Device provides anatomical fit to distal articular surface.

Technological Characteristics

Material: Cobalt chromium alloy (ASTM F1537). Design: One-piece, press-fit hemi-phalangeal prosthesis. Features a polished concave oval disk and a rough, barbed trapezoid stem with a lozenge cross-section.

Indications for Use

Indicated for patients with hallux limitus, hallux rigidus, hallux valgus, arthritic degradation of the metatarso-phalangeal joint, degenerative arthritis, rheumatoid arthritis, and bunion deformity associated with arthritis of the metatarsal-phalangeal joint.

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

• CAPTM Great Toe Resurfacing Hemi-Arthroplasty (K031859)
• BioPro Hemi MP Joint (K041595)

Submission Summary (Full Text)

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14663558

## 3 510(k) Summary of Safety and Effectiveness

| Manufacturer/Sponsor | Arthrex, Inc. 1370 Creekside Boulevard Naples, Florida 34108-1945 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact | Nancy Hoft<br>Regulatory Affairs Associate<br>Telephone: [phone], ext. 1113<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex AnaToemic™ Phalangeal Prosthesis |
| Common Name | Prosthesis, Toe, Hemi-, Phalangeal |
| Product Code | KWD |
| Predicate Devices | K031859, CAPTM Great Toe Resurfacing Hemi-Arthroplasty<br>K041595, BioPro Hemi MP Joint |
| Device Description<br>and Intended Use | The Arthrex AnaToemic™ Phalangeal Prosthesis is a one-piece<br>implant system that replaces only half of the affected joint of the<br>metatarso-phalangeal joint of the big toe.<br>It is anatomically designed to provide an optimal fit to the distal<br>articular surface of the affected joint. The implant has two design<br>elements: 1) a polished, concave oval disk; and, 2) a rough stem<br>with a barbed trapezoid shape with a lozenge cross section. On the<br>stem as well as on the distal portion of the disc the surface is rough.<br>The implant material is cobalt chromium alloy (ASTM F1537).<br>The Arthrex AnaToemic™ Phalangeal Prosthesis is a press-fit<br>implant that is intended to be used in patients with hallux limitus,<br>hallux rigidus, hallux valgus, arthritic degradation of the metatarso-<br>phalangeal joint, degenerative arthritis, rheumatoid arthritis, and<br>bunion deformity associated with arthritis of the metatarsal-<br>phalangeal joint. |
| Substantial<br>Equivalence Summary | Arthrex has determined that the Arthrex AnaToemic™ Phalangeal<br>Prosthesis is substantially equivalent to the predicate device where<br>basic features and intended uses are the same. Any design<br>differences between the Arthrex AnaToemic™ Phalangeal<br>Prosthesis and the predicate device are considered minor and do<br>not raise any questions concerning safety and effectiveness. Any<br>differences have been found to have no apparent effect on the<br>performance, function, or intended use of the device |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arthrex, Inc. % Ms. Nancy Hoft Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108

Re: K063058

Trade/Device Name: Arthrex AnaToemic™ Phalangeal Prosthesis Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: II Product Code: KWD Dated: October 2, 2006 Received: October 6, 2006

JAN - 3 2007

Dear Ms. Hoft:

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 indivious for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate 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, Dr to 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, I usting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, nomd 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 aftecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, IDA may publish further announcements concerning your device in the Federal Regirster.

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 100-1050.

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Page 2 -- Ms. Nancy Hoft

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. Melkerson

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

Enclosure

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2 Indications for Use Form

Indications for Use

53058

510(k) Number:

Device Name:

Arthrex AnaToemic™ Phalangeal Prosthesis

The Arthrex AnaToemic™ Phalangeai Prosthesis is a press-fit implant that is intended to be used in patients with hallux limitus, hallux rigidus, hallux valgus, arthritic degradation of the metatarso-phalangeal joint, degenerative arthritis, theumatoid arthritis, and bunion deformity associated with arthritis of the metatarsal-phalangeal joint.

Prescription Use __ AND/OR Over-The-Counter Use _ (Per 21 CFR 801 Subpart D) (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)
PAGE 1 of

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number L03058

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