SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)

K963618 · Synthes (Usa) · LXT · Nov 12, 1996 · Orthopedic

Device Facts

• Record ID: K963618
• Device Name: SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
• Applicant: Synthes (Usa)
• Product Code: LXT · Orthopedic
• Decision Date: Nov 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes SSEF stabilizes fractures of the distal radius.

Device Story

External fixation system for distal radius fracture stabilization; consists of Schanz screws, adjustable clamps, rods, and end caps. Procedure: small incisions over second metacarpal and radius; insertion of self-drilling Schanz screws using parallel drill guide; adjustable clamps locked onto pins; rods inserted through clamps; end caps applied; fracture reduced; clamps tightened to maintain reduction. Used in clinical/surgical settings by orthopedic surgeons. Provides mechanical stabilization to facilitate bone healing.

Clinical Evidence

Bench testing only; mechanical testing performed to compare performance against predicate device.

Technological Characteristics

Materials: titanium alloy and stainless steel (clamps), carbon fiber reinforced epoxy (rods), polyvinyl chloride (end caps). Mechanical fixation system; non-powered; manual assembly.

Indications for Use

Indicated for stabilization of distal radius fractures in patients 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

• EBI’s Orthofix Penning Dynamic Wrist Fixator

Submission Summary (Full Text)

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SYNTHES
NOV 12 1996

**Attachment IX:** Summary of Safety and Effectiveness Information K963618

| Synthes (USA)
1690 Russell Road
P.O. Box 1766
Paoli, PA 19301 | (610) 647 - 9700
Contact: Angela J. Silvestri
September 1996 |
| --- | --- |

Synthes SSEF is compared to the EBI’s Orthofix Penning Dynamic Wrist Fixator.

The Synthes SSEF stabilizes fractures of the distal radius. The components that make up a SSEF frame include the Schanz screws, adjustable clamps, rods, and end caps. It is anticipated that the most common use of the device would be as follows:

1. A small incision is made over the second metacarpal and radius.
2. Using the Parallel Drill Guide for soft tissue protection and positioning, a pair of Self-Drilling Schanz Screws are inserted into the second metacarpal and radius.
3. An adjustable clamp is slid over each pair of Schanz Screws and tightened to lock on the pins.
4. An appropriately sized rod is slid through each clamp.
5. End caps are applied to each end of the rod to captivate the clamps.
6. The fracture is reduced.
7. The remaining screws on both adjustable clamps are tightened to hold the reduction.

The adjustable clamps of the SSEF are manufactured from a titanium alloy and stainless steel. The rods of the SSEF are manufactured from carbon fiber reinforced epoxy and the end caps of the SSEF are manufactured from polyvinyl chloride.

The EBI’s Orthofix Penning Dynamic Wrist Fixator also stabilizes fractures of the distal radius. It is manufactured from stainless steel and anodized aluminum.

Based on the results of the mechanical testing, Synthes SSEF is at least equivalent to the EBI’s Orthofix Pennig Dynamic Wrist Fixator in performance.