PRACTIFIX EXTERNAL FIXATION SYSTEM
Device Facts
| Record ID | K960014 |
|---|---|
| Device Name | PRACTIFIX EXTERNAL FIXATION SYSTEM |
| Applicant | Orthopaedic Innovations, Inc. |
| Product Code | KTT · Orthopedic |
| Decision Date | Mar 18, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur.
Device Story
External fixation system; utilizes AISI 316L stainless steel pins and carbon-fiber tubes; components connected via pin clamps and bar-bar clamps. System configured to bridge long-bone fractures or non-unions; provides mechanical stability to facilitate bone/soft tissue healing. Operated by surgeons in clinical settings; provides rigid external support for bone segments.
Clinical Evidence
No clinical data provided; substantial equivalence based on design and material characteristics.
Technological Characteristics
Materials: AISI 316L stainless steel pins, carbon-fiber tubes. Components: pin clamps, bar-bar clamps. Function: mechanical external fixation/bridging. Sterilization: not specified.
Indications for Use
Indicated for fracture fixation (open and closed); pseudarthrosis of long bones (congenital and acquired); limb lengthening via epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects.
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
- Hex-Fix External Fixation (Smith and Nephew Richards)
- Day External Fixation (DePuy)
- AP/ASIF External Fixation System (Synthes)
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- K033476 — MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM · Howmedica Osteonics Corp. · Jan 20, 2004
- K232897 — Arthrex Small External Fixation System · Arthrex, Inc. · Oct 18, 2023
