VILEX BONE PLATE SYSTEM

K041287 · Vilex, Inc. · HWC · Aug 5, 2004 · Orthopedic

Device Facts

• Record ID: K041287
• Device Name: VILEX BONE PLATE SYSTEM
• Applicant: Vilex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vilex Bone Plates have the following Indications for Use: Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits. Contra Indications: Elbow, Shoulder, Knee, Hip, Spine, Neck, & Skull

Device Story

Vilex Bone Plate Systems consist of metallic bone plates and accompanying bone screws; used for internal fixation of small-bone fractures and osteotomies in upper and lower extremities (hand, foot, digits). Operated by orthopedic or podiatric surgeons in clinical or surgical settings. Plates provide mechanical stabilization of bone segments to facilitate healing. Device is purely mechanical; no electronic or software components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Implant-quality 316L Stainless Steel (ASTM F-138) and Titanium (ASTM F-136). Mechanical bone fixation system consisting of plates and screws. Non-electronic, non-software, mechanical device.

Indications for Use

Indicated for small-bone fracture and osteotomy in upper and lower extremities, specifically hand, foot, and digits. Contraindicated for use in elbow, shoulder, knee, hip, spine, neck, and skull.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2004

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

Re: K041287

Trade/Device Name: Vilex Bone Plate Systems Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 10, 2004 Received: May 24, 2004

Dear Dr. Lavi:

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 -- Abraham Lavi, Ph.D., MBA

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,

Mark H. Milliken

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 word "VILEX" in a stylized, bold font, with the letters connected and slightly slanted. Below the word "VILEX" is the word "Inc.", which is an abbreviation for Incorporated. The text is black and is set against a white background.

Manufacturer of Vilex™ bone implants, Power equipment & surgical instruments. Phone: [phone] FAX: [phone] www.vilex.com

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

510 (K) NUMBER K 041687

## DEVICE NAME: Vilex Bone Plate Systems

INDICATIONS FOR USE:

The Vilex Bone Plates have the following Indications for Use:

Small-Bone Fracture and Osteotomy in Upper & Lower Extremities, primarily hand, foot, and digits.

Contra Indications: Elbow, Shoulder, Knee, Hip, Spine, Neck, & Skull

The material used to manufacture the bone plates is implant-quality 316L Stainless (ASTM Fric material used to manufacture (ASTM F-136). The plates are to be used with accompanying bone screws of the same material.

Prescription Use _x (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE

f Device Evaluation (ODE)

Mark N Mulkern

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510(k) Number K041287