EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM

K970290 · Ebi, L.P. · KTT · Apr 1, 1997 · Orthopedic

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.)

Submission Summary (Full Text)

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EBI Electro Biology

Enhancing Bone Healing through Applied Science

APR - 1 1997

K970290

# 510(k) SUMMARY FOR THE X FIX™ DynaFix® Mini External Fixation System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

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. External fixators are recommended for Class II by the Orthopedic Panel (Single/Multiple Component Metallic Bone Fixation Appliance, 21 CFR 888.3030).

The EBI X FIX™ DynaFix® Mini External Fixation System is substantially equivalent* to the Orthofix® Mini Fixator and Orthofix® Mini Lengthener (Orthofix® S.R.L., Verona Italy) the Synthes Mini External Fixator (Synthes, USA) and the Hoffman Mini External Fixator (Howmedica, Inc.).

The EBI X FIX™ DynaFix® Mini External Fixation System consists of fixator components and bone screws. The fixator frame consists of fixator rails which are connected by a central component. The fixator frame attaches to the bone via bone screws which penetrate the patient's skin. The fixator frame secures to the shanks of the bone screws with bone screw clamps. The EBI X FIX™ DynaFix® Mini External Fixation System is capable of providing physicians with capability to lengthen. The EBI X FIX™ DynaFix® Mini External Fixation System frame components are composed of aluminum alloy, titanium alloy and stainless steel. The EBI X FIX™ DynaFix® Mini External Fixation System bone screws are made of 316L stainless steel.

Comparative testing of the EBI X FIX™ DynaFix® Mini External Fixation System and the Orthofix® Mini Fixator and Mini Lengthener was performed. The testing included static and fatigue testing. The results demonstrate that in general, the EBI X FIX™ DynaFix® Mini External Fixation System has greater mechanical strength than the Orthofix® Mini Fixator and Mini Lengthener.

In summary, the results of the static and fatigue testing and the comparison of the systems' intended uses, components and designs demonstrate that the EBI X FIX™ DynaFix® Mini External Fixation System is substantially equivalent to the Orthofix® Mini Fixator and Orthofix® Mini Lengthener, the Synthes Mini External Fixator and the Hoffman Mini External Fixator.


* Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977 42 FR 42520 (Docket No. 76N-0355)]

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