VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00

K014154 · Vilex, Inc. · HWC · Mar 18, 2002 · Orthopedic

Device Facts

• Record ID: K014154
• Device Name: VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09; VILEX SOLID BONE SCREWS DB1 THREAD,MODEL F20-XX-00
• Applicant: Vilex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multithread Vilex Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, and Tendon Attachment. It is intended for, but not limited to Hand Surgery, Orthopedic and Podiatric Surgery, The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6Al4V, implant quality titanium alloy.

Device Story

Cannulated bone screw for internal fixation; used in bone fractures, osteotomies, arthrodeses, and tendon attachment. Device provides mechanical stabilization of bone segments. Used by orthopedic, podiatric, or hand surgeons in clinical/surgical settings. Implanted to facilitate healing and structural support.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cannulated bone screw; materials: 316L implant-quality stainless steel and Ti6Al4V implant-quality titanium alloy. Mechanical fixation device.

Indications for Use

Indicated for bone fractures, osteotomies, arthrodeses, and tendon attachment in patients requiring orthopedic, podiatric, or hand surgery.

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.

Predicate Devices

• K991151
• K991197

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K014154

Trade/Device Name: Vilex/Duval/Orthex Cannulated Bone Screw Double Thread Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: December 1, 2001 Received: December 18, 2001

MAR 1 8 2002

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 - Dr. Abrahim Lavi

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis leter will and w yourse by a finding of substantial equivalence of your device to a legally premits to the 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFR Furt 0071 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Miriam C. Provost

Cor 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/1 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 word "Inc." is located to the right of the logo.

Distributors of Orthex™, DuVal™ and Vilex orthopedic implant products, UAM™ Thomas Rose™ surgical instruments

Phone: [phone] [phone] FAX: Orders: [phone] Corporate Offices 345 Old Curry Hollow Road Pittsburgh, Pennsylvania 15236 USA e-mall: [e-mail]

K991151, K991197

page __ 1_____________________________________________________________________________________________________________________________________________________________________

510 (K) NUMBER (IF KNOWN) : __ KO14 154

DEVICE NAME: MULTITHREAD VILEX BONE SCREW

INDICATIONS FOR USE:

The Multithread Vilex Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, and Tendon Attachment. It is intended for, but not limited to Hand Surgery, Orthopedic and Podiatric Surgery, The materials used to manufacture this screw are 316L, implant-quality stainless steel and Ti6Al4V, implant quality titanium alloy.

(Revised 3/5/02)

Prescription Use
X
(Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number K014154