COMPASS UNIVERSAL HINGE

K970713 · Smith & Nephew, Inc., Orthopaedic Div. · JDW · Apr 3, 1997 · Orthopedic

Device Facts

• Record ID: K970713
• Device Name: COMPASS UNIVERSAL HINGE
• Applicant: Smith & Nephew, Inc., Orthopaedic Div.
• Product Code: JDW · Orthopedic
• Decision Date: Apr 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Compass Universal Hinge is a line extension to the Ilizarov external fixation system. It is used in conjunction with the Ilizarov system to treat joint contractures and to restore mobility and function of a joint that has become stiff due to contracture or traumatic injury. The Compass Universal Hinge construct is indicated to treat post-traumatic joint contracture which has resulted in the loss of range of motion, and fractures and disease which generally may result in joint contracture or loss of range of motion.

Device Story

External fixation accessory; attaches to bones on both sides of joint; provides active/passive joint motion; restores range of motion; used in clinical settings by physicians; treats post-traumatic contracture, fractures, and joint stiffness; improves user convenience over existing external fixators.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

External hinge mechanism; mechanical fixation; metallic construction; designed for integration with Ilizarov external fixation system.

Indications for Use

Indicated for patients with post-traumatic joint contracture, fractures, or diseases resulting in loss of range of motion, stiffness, or joint contracture requiring restoration of mobility and function.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Ilizarov External Fixator (Smith & Nephew)
• Dynamic Joint Distractor (Howmedica)

Submission Summary (Full Text)

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APR - 3 1997
K970713

# Summary of Safety and Effectiveness
## Compass Universal Hinge

## Substantial Equivalence Information

The Compass Universal Hinge is similar to Smith & Nephew’s Ilizarov External Fixator and Howmedica’s Dynamic Joint Distractor. All of these devices use external fixation to treat joint contracture or fractures and diseases that may lead to joint contracture. The Compass Universal Hinge represents improvements that enhance user convenience.

## Device Description

The Compass Universal Hinge is a device used with external fixation devices for the indications listed previously. The Compass Universal Hinge is applied to bones on both sides of a joint to provide active and passive motion of the joint and to restore loss of range of motion due to contracture.

## Indications for Use

The Compass Universal Hinge is a line extension to the Ilizarov external fixation system. It is used in conjunction with the Ilizarov system to treat joint contractures and to restore mobility and function of a joint that has become stiff due to contracture or traumatic injury. The Compass Universal Hinge construct is indicated to treat post-traumatic joint contracture which has resulted in the loss of range of motion, and fractures and disease which generally may result in joint contracture or loss of range of motion.

CH02196A
CONFIDENTIAL