PF2

K012062 · Fixano SA · KTT · Sep 27, 2001 · Orthopedic

Device Facts

• Record ID: K012062
• Device Name: PF2
• Applicant: Fixano SA
• Product Code: KTT · Orthopedic
• Decision Date: Sep 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fixano PF2 wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

Device Story

PF2 is a balljoint-hinged external fixator for upper extremity applications; provides rotation and angulation for fracture management. Used by surgeons in clinical settings for reduction, alignment, and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities. Device functions as a mechanical fixation appliance; provides structural support to bone segments during healing. Benefits include stabilization of complex fractures and deformities through adjustable mechanical positioning.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Metallic external bone fixation appliance; balljoint-hinged design allowing for rotation and angulation. Classified under 21 CFR 888.3030 (Product Code KTT).

Indications for Use

Indicated for patients requiring reduction, alignment, and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities in the upper extremity.

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

• EBI XFIX DFS Wristfix System (K993649)

Submission Summary (Full Text)

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SEP 2 7 2001

KO12062

## 510(K) SUMMARY

Manufacturer:

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

Submitted By:

Ferquson Medical Consultant to Fixano S.A.

Single/multiple component metallic bone Classification Name: fixation appliances and accessories.

> External others.

PF2

Common/Usual Name:

Proprietary Name:

21 CFR 888.3030/Procode 87 KTT Classification Number:

Substantial Equivalence:

Device Description:

Intended Use:

Technological Characteristics:

others.

EBI XFIX DFS Wristfix System (K993649) and

fixation device, wrist fixator, and

The device is a balljoint-hinged external fixator capable of rotation and anqulation.

The intended use is similar to that for other external fixators.

The PF2 device is similar in its 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three profiles of human faces.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 7 2001

Mr. Frank Ferguson C/o Fixano S.A. Ferguson Medical P.O. Box 12038 La Jolla, California 92039-2038

Re: K012062 Trade/Device Name: PF2 Regulation Number: 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: II Product Code: KTT Dated: May 25, 2001 Received: July 2, 2001

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 ror answer 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 11 Jour artise 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" (21CFR 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,

Marke n Millken

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): KV / 2062

Device Name: PF2

Indications For Use:

The Fixano PF2 wrist fixation device is intended for use in upper extremity applications for the reduction, alignment and stabilization of intraarticular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N. Mulkeen

(Division Sign-Off) (Division Sign of General, Restorative Division ological Devices KOI 2062

510(k) Number --

Prescription Use _ XX (Per 21 CFR 801.109)

OR OR ..

Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________