CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)

K960659 · Wrightmedicaltechnologyinc · KYI · Feb 6, 1997 · Orthopedic

Device Facts

• Record ID: K960659
• Device Name: CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
• 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 Ceramic 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

Ceramic spherical spacer for carpometacarpal (CMC) joint resection arthroplasty; preserves joint relationship; facilitates capsuloligamentous reconstruction. Implant sits in spherical cavity formed by trapezium and first metacarpal; articulates directly on bone. Used by orthopedic surgeons in clinical settings to treat degenerative or post-traumatic arthritis. Benefits include deformity correction and joint space maintenance.

Clinical Evidence

Bench testing only; material strength testing performed.

Technological Characteristics

Materials: Alumina or zirconia ceramic. Form factor: Spherical implant. Principle: Mechanical spacer for joint arthroplasty. Articulation: Direct bone-to-implant interface.

Indications for Use

Indicated for patients with degenerative or post-traumatic arthritis of the carpometacarpal (CMC) joint presenting with localized pain, palpable crepitation during grind test, decreased motion, normal pinch/grip strength, and radiographic evidence of arthritic changes or subluxation. May be used in cases with associated unstable, stiff, or painful distal joints.

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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WRIGHT
MEDICAL TECHNOLOGY, INC.
5677 VIRGINIA ROAD
ARLINGTON, IN 48002
901-867-9971

Contact Person: Cliff Kline
Date: February 14, 1996

K960659

# 510(k) SUMMARY

FEB - 6 1997

Trade/Proprietary Name: Ceramic 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 Ceramic 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 Ceramic Spherical CMC Implant is made from alumina or zirconia ceramic.

## Testing

The Ceramic Spherical CMC Implant demonstrates acceptable material strength.

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