SYNTHES MINI EXTERNAL FIXATOR

K961350 · Synthes (Usa) · KTT · Jun 28, 1996 · Orthopedic

Device Facts

• Record ID: K961350
• Device Name: SYNTHES MINI EXTERNAL FIXATOR
• Applicant: Synthes (Usa)
• Product Code: KTT · Orthopedic
• Decision Date: Jun 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes Mini External Fixator stabilizes and provides treatment for fractures of the hand and foot.

Device Story

External fixation system for hand and foot fractures; components include threaded Kirschner wires, wire-to-rod clamps, rod-to-rod clamps, rods, and angled connecting bar. Procedure: K-wires inserted into proximal/distal fracture fragments using soft tissue protector; clamps and rods attached to wires; fracture repositioned; nuts tightened to secure construct; K-wires cut. Used by surgeons in clinical settings to provide rigid stabilization during fracture healing.

Clinical Evidence

Bench testing only. Mechanical testing performed to compare stiffness and fixation strength against Howmedica Mini Hoffmann External Fixation System; results indicate Synthes device is at least equivalent to or stiffer than predicate.

Technological Characteristics

Components: Threaded Kirschner wires (stainless steel), clamps (stainless steel), angled connecting bar (stainless steel), rods (carbon fiber reinforced epoxy). Mechanical fixation principle. Non-sterile; requires sterilization by user.

Indications for Use

Indicated for patients requiring stabilization and treatment of fractures of the hand and foot.

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

• Howmedica Mini Hoffmann External Fixation System

Submission Summary (Full Text)

{0}

SYNTHES

JUN 28 1996

K961350

Attachment B: Summary of Safety and Effectiveness Information [510(k) Summary]

SYNTHES (USA)
1690 Russell Road
Paoli, PA 19301

[phone]
Contact: Angela Silvestri
June 1996

Device: Synthes Mini External Fixator is compared to the Howmedica Mini Hoffmann External Fixation System.

The Synthes Mini External Fixator stabilizes and provides treatment for fractures of the hand and foot. Synthes Mini External Fixator includes the following components: Threaded Kirschner Wires, Wire-to-Rod and Rod-to-Rod Clamps, Rods and an Angled Connecting Bar. It is anticipated that the most common use of the device would be as follows:

1. A K-wire is inserted into the proximal and distal fracture with the help of a soft tissue protector.
2. Slide one clamp over each K-wire; slide rod through both clamps.
3. After the fracture is repositioned, securely tighten the nuts for the K-wire and the rod.
4. Place the two remaining K-wires through the two clamp openings.
5. Tighten all clamp nuts.
6. Cut K-wires.

The wires are manufactured from stainless steel; the clamps and angled connecting bar from various grades of stainless steel, the rods from carbon fiber reinforced epoxy.

The Howmedica Mini Hoffmann External Fixation System is also intended for immediate reduction and stabilization of fractures of the hand, wrist, foot and maxillofacial area. It is manufactured from stainless steel.

Based on the results of the mechanical testing, Synthes Mini External Fixator provides fixation that is at least equivalent to or stiffer than the Howmedica Mini Hoffmann External Fixation System.