SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)

K962484 · Synthes (Usa) · KTT · Sep 5, 1996 · Orthopedic

Device Facts

• Record ID: K962484
• Device Name: SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC)
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Sep 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Ti External Fixator Clamps are used in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation.

Device Story

External fixator clamps used to construct frames for long bone fracture treatment; components connect rods/pins to stabilize fractures; operated by orthopedic surgeons in clinical/OR settings; provides mechanical stability to bone segments during healing; benefits include rigid fixation and fracture alignment.

Clinical Evidence

Bench testing only; mechanical property comparison of materials.

Technological Characteristics

Materials: Titanium-6% Aluminum-7% Niobium (Ti-6Al-7Nb) or Titanium-6% Aluminum-4% Vanadium (Ti-6Al-4V) alloy. Mechanical fixation clamps for external frames.

Indications for Use

Indicated for patients with long bone fractures requiring external 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

• Synthes Hybrid External Fixator clamps
• Synthes Titanium Universal Clamp
• Synthes Ti Tube to Tube Clamp

Submission Summary (Full Text)

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SEP 5 1996

K962484

# Syntheses

## Attachment VI: Summary of Safety and Effectiveness Information

Synthes (USA)
1690 Russell Road
P.O. Box 1766
Paoli, PA 19301

(610) 647 - 9700
Contact: Angela J. Silvestri
June 24, 1996

Synthes Ti External Fixator Clamps are compared to Synthes Hybrid External Fixator clamps, Synthes Titanium Universal Clamp, and Synthes Ti Tube to Tube Clamp.

Synthes Ti External Fixator Clamps are used in the construction of an external fixation frame for the treatment of long bone fractures that require external fixation. The Ti External Fixator Clamps are manufactured from Titanium-6% Aluminum-7% Niobium (Ti-6Al-7Nb) or a Titanium-6% Aluminum-4% Vanadium (Ti-6Al-4V) alloy.

Based on the mechanical properties for the Ti-6Al-7Nb material, the External Fixator Clamps will perform at least equivalent to Ti-6Al-4V External Fixator Clamps.