MICROFIX

K023314 · Fixano SA · KTT · Oct 18, 2002 · Orthopedic

Device Facts

• Record ID: K023314
• Device Name: MICROFIX
• Applicant: Fixano SA
• Product Code: KTT · Orthopedic
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fixano MICROFIX device is intended for use in the external fixation of fractures and/or reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.

Device Story

The MICROFIX is a radiolucent external fixator used for the stabilization of small bone fractures and reconstruction procedures. It is intended for use in clinical settings by healthcare professionals. The device functions as a mechanical support system to maintain bone alignment during the healing process. It is applied to the patient's anatomy to provide external fixation, aiding in the management of metacarpal and metatarsal injuries.

Technological Characteristics

Radiolucent external fixator for small bone fixation. Metallic components. Class II device under 21 CFR 888.3030.

Indications for Use

Indicated for external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal bones in patients requiring such orthopedic intervention.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Minifix (K964094)

Submission Summary (Full Text)

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OCT 1 8 2002

K023314

## 510(K) SUMMARY

| Manufacturer: | Fixano S.A.<br>Z.A. Les Bruyeres<br>01960 Peronnas<br>France |
|--------------------------------|--------------------------------------------------------------------------------------------------------------|
| Submitted By: | Ferguson Medical<br>Consultant to Fixano S.A. |
| Classification Name: | Single/multiple component metallic<br>bone<br>fixation appliances and accessories. |
| Common/Usual Name: | External fixation device, external fixator, and<br>others. |
| Proprietary Name: | MICROFIX |
| Classification Number: | 21 CFR 888.3030/Procode 87 KTT |
| Substantial Equivalence: | Minifix (K964094) and others. |
| Device Description: | The device is a radiolucent external fixator. |
| Intended Use: | The intended use is similar to that for other<br>external fixators. |
| Technological Characteristics: | The MICROFIX device is similar in its intended<br>use to predicate devices<br>and existent<br>methodologies. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest the bird's head and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

## Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

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

Re: K023314

Trade/Device Name: Microfix Regulation Number: 888.3030 Regulation Name: Single/Multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: September 1, 2002 Received: September 3, 2002

Dear Mr. Ferguson:

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. Iisting 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 – Mr. Frank Ferguson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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 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.

b. Mark McMillan

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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510(k) Number (If known):

Device Name: MICROFIX

Indications For Use:

The Fixano MICROFIX device is intended for use in the external fixation of fractures and/or reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Melkerson

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

510(k) Number K023314

Prescription Use _ XX (Per 21 CFR 801.109)

OR

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________