FLEX-NAILS

K012161 · Fixano SA · HTY · Aug 24, 2001 · Orthopedic

Device Facts

• Record ID: K012161
• Device Name: FLEX-NAILS
• Applicant: Fixano SA
• Product Code: HTY · Orthopedic
• Decision Date: Aug 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fixano FLEX-NAILS are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, or implantation through the skin so that traction may be applied to the skeletal system.

Device Story

FLEX-NAILS are flexible titanium intramedullary nails used for orthopedic bone fixation. Device functions as a mechanical fastener for bone fractures or reconstructions; serves as a guide pin for other implants; or provides skeletal traction via percutaneous insertion. Used by orthopedic surgeons in clinical or surgical settings. Device provides mechanical stabilization of bone segments to facilitate healing.

Technological Characteristics

Flexible titanium intramedullary nail. Metallic bone fixation fastener. Form factor includes nails and pins.

Indications for Use

Indicated for patients requiring bone fracture fixation, bone reconstruction, use as guide pins for other implants, or skeletal traction via percutaneous implantation.

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

• Nancy Nail (preamendment device)
• DePuy Sterile Kirschner Wires and Steinmann Pins (K960385)
• Syntec-Taichung Nonsterile Kirschner Wires and Steinmann Pins (K983121)

Submission Summary (Full Text)

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AUG 2 4 2001

K012161

## 510(K) SUMMARY

Manufacturer:

Fixano S.A. Z.A. Les Bruyeres 01960 Peronnas France

Submitted By:

Ferguson Medical Consultant to Fixano S.A.

Smooth or threaded metallic bone fixation

Intramedullary nail, fixation pin, and others.

Classification Name:

Common/Usual Name:

FLEX-NAILS Proprietary Name:

21 CFR 888.3040/Procode 87 HTY Classification Number:

fastener.

Nancy Nail preamendment device. Substantial Equivalence: DePuv DePuy Sterile Kirschner Wires and Steinmann Pins device (K960385) Syntec-Taichung Nonsterile Kirschner Wires and Steinmann Pins (K983121)

The device is a flexible titanium nail for Device Description: orthopedic implantation.

The intended use is similar to that for other Intended Use: implantable intramedullary nails.

The FLEX-NAILS device is similar in ારિ Technological Characteristics: intended use to predicate devices and existent methodologies.

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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 with three lines forming its body and head. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

AUG 2 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Fixano SA c/o Mr. Frank Ferguson Ferguson Medical P.O. Box 12038 La Jolla, California 92039-2038

Re: K012161

Trade Name: FLEX-NAILS Regulation Number: 888.3040 Regulatory Class: II Product Codes: HTY Dated: June 15, 2001 Received: July 11, 2001

Dear Mr. Ferguson:

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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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.

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Page 2 - Mr. Frank Ferguson

This letter will allow you to begin marketing your device as described in your 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 and 11 you desire spooline a in vitro diagnostic devices), please contact the Office of Compliance at additionally 60711 o ditionally, for questions on the promotion and advertising of your device, (1 see contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

L. Mark McMullerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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## 510(k) Number (If known): K 01216 (

Device Name: FLEX-NAILS

Indications For Use:

Fixano FLEX-NAILS are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, or implantation through the skin so that traction may be applied to the skeletal system.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Melhusen

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

510(k) Number K012161

Prescription Use XX (Per 21 CFR 801.109)

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________