VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW

K973309 · Vilex, Inc. · HWC · Jan 16, 1998 · Orthopedic

Device Facts

• Record ID: K973309
• Device Name: VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW
• Applicant: Vilex, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jan 16, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vilex/DuVal Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. The material used to manufacture this screw is 316L, implant-quality stainless steel. When properly used with Vilex instrumentation, this screw achieves safe purchase and compression for cortical and cancellous bone fixation in the human body.

Device Story

Cannulated bone screw system; used for internal fixation of bone fractures, osteotomies, arthrodeses, osteochondritis, and tendon reattachment. Device provides mechanical purchase and compression in cortical and cancellous bone. Operated by surgeons in clinical settings (hand, orthopedic, plastic, podiatric surgery). Used in conjunction with Vilex instrumentation. Output is physical stabilization of bone segments; aids in healing and structural alignment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manufactured from 316L implant-quality stainless steel. Cannulated design for guided placement. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for bone fractures, osteotomies, arthrodeses, osteochondritis, and tendon reattachment in patients undergoing hand, orthopedic, plastic, or podiatric surgery. Contraindicated for pedicular screw fixation/attachment to the cervical, thoracic, or lumbar vertebral column.

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

Abraham Lavi, Ph.D., M.B.A. · President / CEO Vilex, Inc. P.O. Box 724 811 Route 51 Industrial Complex Building 10 Large, Pennsylvania 15025

Re: K973309 Vilex/DuVal Cannulated Bone Screw Regulatory Class: II Product Code: HWC Dated: December 10, 1997 December 16, 1997 Received:

Dear Dr. Lavi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the qeneral 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of This-device, if intended for use in-pedicular screw ……… the Act. fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513 (f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

- 1. The package insert must prominently state that the device is intended for the specific use(s) described in the enclosure only; and
JAN 1 6 1998

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Page 2 - Abraham Lavi, Ph.D., M.B.A.

- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, "WARNING: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Druq Administration (FDA) prior to conduct of the investigation.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

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If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K973309/41

510(k) Number (if known): K973309

Device Name: Vilex Cannulated Bone Screw, DuVal Cannulated Bone Screw

Indications For Use:

The Vilex/DuVal Cannulated Bone Screw, as designed, has the following Indications for Use: Bone Fractures, Osteotomies, Arthrodeses, Osteochrondritis and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, Plastic Surgery and Podiatric Surgery. The material used to manufacture this screw is 316L, implant-quality stainless steel. When properly used with Vilex instrumentation, this screw achieves safe purchase and compression for cortical and cancellous bone fixation in the human body.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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| Division of General Restorative Devices | |
| 510(k) Number | K973309 |

Prescription Use (Per 21 CFR 801.109)

OH

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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