EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
Device Facts
| Record ID | K970290 |
|---|---|
| Device Name | EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM |
| Applicant | Ebi, L.P. |
| Product Code | KTT · Orthopedic |
| Decision Date | Apr 1, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The EBI X FIX™ DynaFix® Mini External Fixation System is a unilateral external fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Device Story
Unilateral external fixation system for bone stabilization; treats fractures, osteotomies, arthrodesis, and leg lengthening. System comprises fixator rails, central component, and bone screws. Physician attaches frame to bone via percutaneous screws; clamps secure frame to screw shanks. Provides mechanical support for bone healing; enables limb lengthening. Used in clinical settings by orthopedic surgeons. Mechanical design provides structural stability to bone segments. Benefits patient by facilitating bone alignment and healing in various orthopedic conditions.
Clinical Evidence
Bench testing only. Comparative static and fatigue testing performed against Orthofix Mini Fixator and Mini Lengthener. Results indicate subject device exhibits greater mechanical strength than predicate systems.
Technological Characteristics
Unilateral external fixator. Materials: aluminum alloy, titanium alloy, stainless steel (frame); 316L stainless steel (bone screws). Mechanical fixation via bone screws and clamps. No software or electronic components.
Indications for Use
Indicated for patients requiring bone stabilization or correction, including leg lengthening, osteotomies, arthrodesis, and fracture fixation.
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
- Orthofix® Mini Fixator (Orthofix® S.R.L.)
- Orthofix® Mini Lengthener (Orthofix® S.R.L.)
- Synthes Mini External Fixator (Synthes, USA)
- Hoffman Mini External Fixator (Howmedica, Inc.)
Related Devices
- K101375 — TRIMED X-FIX · TriMed, Inc. · Sep 15, 2010
- K974911 — EXTERNAL FIXATOR · Avanta Orthopaedics, Inc. · Mar 16, 1998
- K013378 — EBI XFIX DFS SYSTEM · Ebi, L.P. · Nov 8, 2001
- K981716 — EXTERNAL FIXATION · Avanta Orthopaedics, Inc. · Jul 17, 1998
- K162032 — Arrowhead Mini-Rail Fixator · Arrowhead De, LLC · Feb 21, 2017
