TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION

K990848 · Immedica, Inc. · LXT · May 17, 1999 · Orthopedic

Device Facts

• Record ID: K990848
• Device Name: TRANSFX INTERMEDIATE EXTERNAL FIXATION SYSTEM,TRANSFX SMALL EXTERNAL FIXATION SYSTEM, TRANSFX MINI EXTERNAL FIXATION
• Applicant: Immedica, Inc.
• Product Code: LXT · Orthopedic
• Decision Date: May 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary fixation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.

Device Story

TransFx External Fixation System (Intermediate, Small, and Mini variants) provides skeletal stabilization for orthopedic fractures and reconstructive procedures. Device consists of external fixation hardware applied by surgeons in clinical or surgical settings to stabilize bone segments. System maintains fracture reduction via external frame; facilitates healing through rigid immobilization of bone fragments. Used for distal radius fractures, long bone fractures, joint fusions, and osteotomies. Surgeon selects appropriate system size based on anatomical site and fracture complexity. Output is mechanical stabilization of bone; assists clinical decision-making by providing stable environment for bone union.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External fixation system comprising frames and hardware for bone stabilization. Materials and specifications not detailed in provided text. Mechanical fixation principle; non-powered; manual operation.

Indications for Use

Indicated for patients with unstable distal radius fractures (intra-articular, extra-articular, or preliminary fixation) and fractures/dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones. Also indicated for joint fusion, osteotomies, and peri-articular fractures.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 1999

Mr. Roy Bogert Director of R&D and Regulatory Affairs Immedica, Inc. 100 Passaic Avenue Chatham, New Jersey 07928

Re : K990848 TransFx Intermediate External Fixation System TransFx Small External Fixation System TransFx Mini External Fixation System Regulatory Class: II Product Code: LXT March 11, 1999 Dated: March 15, 1999 Received:

Dear Mr. Bogert:

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 general controls provisions The general controls provisions of the Act 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 requirement, 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 requlation may result in requlatory 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 !.aws or regulations.

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Page 2 - Mr. Roy Bogert

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 additionally 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 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,

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

Enclosure

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**510(k) Number (if known):**

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

TransFx Small External Fixation System Device Name: TransFx Intermediate External Fixation System TransFx Mini External Fixation System

## Indications For Use:

Unstable fractures of the distal radius: intra-articular, extra-articular, and preliminary fixation before internal fixation. Fractures and fracture dislocations of the hand, wrist, forearm, mandible, foot, ankle, and long bones; joint fusion, osteotomies, and peri-articular fractures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

bocella

(Division Sign-Off)
Division of General Restorative Devices K990848
510(k) Number

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

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