CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365

K023684 · Vilex, Inc. · KWD · Mar 1, 2004 · Orthopedic

Device Facts

• Record ID: K023684
• Device Name: CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365
• Applicant: Vilex, Inc.
• Product Code: KWD · Orthopedic
• Decision Date: Mar 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hallux Limitus or Hallux Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing of Arthritic M-P Joints.

Device Story

Cannulated Metallic Hemi Toe Implant is a metallic prosthesis designed for surgical implantation in the foot. Used for M-P joint arthroplasty and resurfacing to address Hallux Limitus, Hallux Rigidus, and Hallux Valgus. Implanted by orthopedic or podiatric surgeons in a clinical or hospital setting. The device is manufactured from implant-quality cobalt-chrome alloy (ASTM F75). It features a cannulated design allowing for either cemented fixation to the phalanx or press-fit installation. By replacing or resurfacing the damaged joint surface, the implant aims to restore joint function and alleviate pain associated with arthritic conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Cobalt-chrome alloy (ASTM F75). Design: Cannulated metallic hemi-toe prosthesis. Fixation: Cemented or press-fit. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring joint arthroplasty or resurfacing of arthritic metatarsophalangeal (M-P) joints due to conditions including Hallux Limitus, Hallux Rigidus, or Hallux Valgus.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 with three stripes representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1 2004

Abrahim Lavi, Ph.D., MBA President Vilex, Inc. 345 Old Curry Hollow Road Pittsburg, Pennsylvania 15236

Rc: K023684

. 1802500 For Name: Cannulated Metallic Hemi Toe Implant Regulation Number: 21 CFR 888.3730 Regulation Name: Toe joint phalangeal (hemi-toe) polymer prosthesis Regulatory Class: Il Product Code: KWD Dated: December 29, 2003 Received: January 8, 2004

Dear Dr. Lavi:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and nave determined the marketed predicate devices marketed in interstate for use stated in the encrosary w regars and the Medical Device Amendments, or to commerce province way 20, 1978, the exactions 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 I ou may, merciolo, manel the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is elassince (600 wor of ols. Existing major regulations affecting your device can may be subject to sublications, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.

Please be advised that FDA`s issuance of a substantial equivalence determination does not mean Flease be advised that I DA 3 issuance or our device complies with other requirements of the Act that I DX has made a acteriminations administered by other Federal agencies. You must or any it caefar statuted and registements, including, but not limited to: registration and listing (21 Compry with an the Her STOC STORES, 10, good manufacturing practice requirements as set CI K I all 607), navelling (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Abrahim Lavi, Ph.D., MBA

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin maneting your aviate of your dever to a legally premaince nothleadon: The FDA maing of easification 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 If you desire specific advice for your act [phone]. Also, please note the regulation entitled, Comaci the Office of Comphance at (3st notification" (21CFR Part 807.97). You may obtain "Misoranuming by reference to premainters inculties under the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Milken

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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Image /page/2/Picture/0 description: The image shows the logo for VILEX Inc. The logo is in black and white and features the word "VILEX" in a stylized font. The letters are bold and angular, and the "X" has a unique design. To the right of the logo is the word "Inc."

Manufacturer of Vilex™ bone implants, Power equipment & surgical instruments. Phone: [phone] (412) 655-755) FAX: www.vilex.com

345 Old Curry Hollow Road Pittsburgh, PA 15236 USA E-mail: [e-mail]

## 510 (K) NUMBER K023684

## DEVICE NAME: CANNULATED METALLIC HEMI TOE IMPLANT

## INDICATIONS FOR USE:

The Cannulated Metallic Toe Implant, as designed, has the following Indications for Use:

Hallux Limitus or Hallux Rigidus, Hallux Valgus, Joint Arthroplasty, Resurfacing of Arthritic M-P Joints.

The material used to manufacture this prosthesis is implant-quality cobalt-chrome alloy ASTM F75. The implant may be cemented to the phalanx or press-fit without cernent.

Prescription Use
(Per 21 CFR 801.109) X

Concurrence of CDRH, Office of Device Evaluation (ODE)

page 1 of 1, Revised 12/29/03

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

510(k) Number K023684