ILIZAROV EXTERNAL FIXATION SYSTEM

K962808 · Smith & Nephew Richards, Inc. · KTT · Aug 19, 1996 · Orthopedic

Device Facts

• Record ID: K962808
• Device Name: ILIZAROV EXTERNAL FIXATION SYSTEM
• Applicant: Smith & Nephew Richards, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Aug 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The titanium washers and titanium wires of the Ilizarov External Fixation System are single use devices designed for patients with the following indications: open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of bony or soft tissue defects. Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone. These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities.

Device Story

Titanium wires and washers for Ilizarov External Fixation System; intended for patients with stainless steel sensitivity. Wires attach to circular fixator rings/rods; olive-shaped stopper creates interfragmentary compression/stability. Washers distribute load for wire with stopper, particularly in osteoporotic bone. Used by orthopedic surgeons in clinical settings for fracture management and deformity correction. Provides alternative material for patients with metal allergies while maintaining mechanical function of existing stainless steel components.

Clinical Evidence

Bench testing only. Fatigue testing performed on titanium wires; results demonstrated performance comparable to stainless steel wires.

Technological Characteristics

Materials: Titanium. Components: Wires (with/without olive-shaped stopper) and washers. Function: Interconnects with Ilizarov External Fixator System rings and rods. Single-use.

Indications for Use

Indicated for patients requiring open/closed fracture fixation, pseudoarthrosis/nonunions of long bones, limb lengthening, or correction of bony/soft tissue deformities/defects. Specifically for patients with stainless steel sensitivity/allergy.

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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AUG 19 1996

K 962808

# Summary of Safety and Effectiveness

Smith & Nephew Orthopaedics

## Ilizarov External Fixation System - Titanium Washers, Titanium Wires, and Titanium Wires with Olive Shaped Stopper

The titanium washers and titanium wires of the Ilizarov External Fixation System are single use devices designed for patients with the following indications: open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of bony or soft tissue defects. Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone. These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities.

The titanium wires and washers have the same function as the existing stainless steel wires and washers. They are made of titanium for patients who have a sensitivity to stainless steel. The titanium components are primarily for patients that have allergy sensitivities.

The washer and wires interconnect with the Ilizarov External Fixator System. The wires are inserted and attached to the rings of the circular fixator and rods of the Ilizarov External Fixator System. The wires are available with an olive shaped stopper to create interfragmentary compression or to add more stability to the assemblage. The washer may be used with the wires with stopper to provide surface area for the stopper to push up against.

The testing of these devices centered primarily on the following parameters: fatigue testing of the titanium wires. The results were acceptable and the titanium wire should perform as well as the stainless steel wire.