EXTERNAL FIXATION

K052605 · Gexfix USA, Inc. · KTT · Nov 10, 2005 · Orthopedic

Device Facts

• Record ID: K052605
• Device Name: EXTERNAL FIXATION
• Applicant: Gexfix USA, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Nov 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) BONE FRACTURE FIXATION 2) OSTEOTOMY 3) ARTHODESIS 4) CORRECTION OF DEFORMITY 5) REVISION PROCEDURES WHERE OTHER DEVICES HAVE BEE UNSUCCESSFUL 6) BONE RECONSTRUCTION PROCEDURES

Device Story

External Fixation system used for stabilization of bone segments. Device consists of metallic bone fixation fasteners; used by orthopedic surgeons in clinical settings. Provides mechanical support to bone during healing process; facilitates fracture fixation, osteotomy, arthrodesis, deformity correction, and bone reconstruction. Surgeon manually applies device to patient; output is physical stabilization of bone. Benefits include restoration of skeletal alignment and support for bone union.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Metallic bone fixation fastener system. Class II device. Regulation 21 CFR 888.3030. Single/multiple component metallic construction.

Indications for Use

Indicated for patients requiring bone fracture fixation, osteotomy, arthrodesis, deformity correction, bone reconstruction, or revision procedures where prior treatments failed.

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.

Submission Summary (Full Text)

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K 05260

NOV 1 0 2005

Image /page/0/Picture/2 description: This image shows a document titled "PREMARKET NOTIFICATION SUBMISSION - 510 (k)". The document includes the date 09-15-2005 and page number 1 di 28. It provides a 510 (k) summary, including the applicant GexFix USA Inc. located at 1200 Clint Moore Rd. Suite # 1, Boca Raton, FL 33487, the contact person Mr. Lucio Improta, and the submission date May 15th, 2005.

- > Trade Name : External Fixation
- > Common Name : External Fixation System
- > Classification Name : Smooth or threaded metallic bone fixation fastener
- > Reg. # 888-3040 -..
- > Panel Code : Orthopedic
- > Prod. Code : KTT

## Indication for use :

The indication for use of this device are:

- 1) Bone fracture fixation;
- 2) Osteotomy
- 3) Arthodesis
- 4) Correction of deformity
- 5) Revision procedures where other treatments oe devices have been unsuccessful Bone reconstruction procedures

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and health. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

NOV 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lucio Improta GexFix USA, Inc. 1200 Clint Moore Road, Suite # 1 Boca Raton, Florida 33487

Re: K052605 Trade/Device Name: EXTERNAL FIXATION Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 15, 2005 Received: September 23, 2005

Dear Mr. Improta:

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 -Lucio Improta

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

Mark N. Melkonian

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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J.S. Food and Drug Admini

CENTER FOR DEVICES AND RADIOT OCCIC

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## Indications for Use

510(k) Number (if known): K052605

Device Name: EXTERNAL FIXATION

Indications for Use:

- 1) BONE FRACTURE FIXATION
- 2) OSTEOTOMY
- 3) ARTHODESIS
- 4) CORRECTION OF DEFORMITY
- 5) REVISION PROCEDURES WHERE OTHER DEVICES HAVE BEE UNSUCCESSFUL
- 6) BONE RECONSTRUCTION PROCEDURES

signature

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

510(k) Number_Kos2pos

AND/OR

Prescription Use _X (Part 21 CFR 801 Subpart D) Over-The-Counter Use

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)