METALLIC SPHERICAL CMC IMPLANT

K960534 · Wrightmedicaltechnologyinc · KYI · Feb 6, 1997 · Orthopedic

Device Facts

• Record ID: K960534
• Device Name: METALLIC SPHERICAL CMC IMPLANT
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KYI · Orthopedic
• Decision Date: Feb 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3770
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Metallic Spherical CMC Implant is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or post-traumatic arthritis limited to that joint. It acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. The implant will rest in a spherical cavity created by two hemispherical shapes in the trapezium and the first metacarpal. The implant will articulate directly on bone.

Device Story

Metallic Spherical CMC Implant; cobalt chrome alloy spacer for resection arthroplasty of carpometacarpal (CMC) joint. Device placed in spherical cavity formed by trapezium and first metacarpal; articulates directly on bone. Used by surgeons to preserve joint relationship and facilitate capsuloligamentous reconstruction in arthritis cases. Benefits include deformity correction and joint stabilization.

Clinical Evidence

Bench testing only; device demonstrates acceptable material strength.

Technological Characteristics

Material: Cobalt chrome alloy. Form factor: Spherical implant. Function: Articulates directly on bone within a prepared spherical cavity.

Indications for Use

Indicated for patients with isolated carpometacarpal joint degenerative or post-traumatic arthritis presenting with localized pain, palpable crepitation during grind test, decreased motion, normal pinch/grip strength, and radiographic evidence of arthritic changes or subluxation.

Regulatory Classification

Identification

A wrist joint carpal trapezium polymer prosthesis is a one-piece device made of silicone elastomer or silicone elastomer/polyester material intended to be implanted to replace the carpal trapezium bone of the wrist.

Predicate Devices

• Swanson Titanium Condylar Implant

Submission Summary (Full Text)

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FEB - 6 1997
K960534

Contact Person: Cliff Kline
Date: February 6, 1996

# 510(k) SUMMARY

| Trade/Proprietary Name: | Metallic Spherical CMC Implant |
| --- | --- |
| Common Name: | Carpometacarpal (CMC) implant |
| Product Nomenclature: | Prosthesis, wrist, carpal trapezium |
| Classification: | Class II |
| Predicate Device: | Swanson Titanium Condylar Implant |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

## Description/Intended Use

The Metallic Spherical CMC Implant is intended to be used as an adjunct to resection arthroplasty of the carpometacarpal (CMC) joint in cases of degenerative arthritis or post-traumatic arthritis limited to that joint. It acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities. The implant will rest in a spherical cavity created by two hemispherical shapes in the trapezium and the first metacarpal. The implant will articulate directly on bone.

Use of the CMC Implant may be considered in cases of isolated carpometacarpal joint involvement from either degenerative or post-traumatic arthritis presenting:

- Localized pain and palpable crepitation during circumduction movement with axial compression of involved thumb ("grind test").
- Decreased motion, normal pinch and grip strength.
- X-ray evidence of arthritic changes and/or subluxation of the carpometacarpal joint.
- Associated unstable, stiff, or painful distal joints.

The Metallic Spherical CMC Implant is made from cobalt chrome alloy.

## Substantial Equivalence

The Metallic Spherical CMC Implant is substantially equivalent to the Swanson Titanium Condylar Implant

## Testing

The Metallic Spherical CMC Implant demonstrates acceptable material strength.

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