# K960534: Metallic Spherical CMC Implant

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Feb 6, 1997 after 365 days
- Product code: KYI (Prosthesis, Wrist, Carpal Trapezium)
- Device class: 2
- Regulation: 21 CFR 888.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Swanson Titanium Condylar Implant: named in the summary without a submission number

## Most influential descendants
- K092548: Extremity Medical Trapezium Prosthesis (2009), 1 descendant of its own
- K201072: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (2020), 0 descendants of its own

## Indications for 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.

Source page: https://510kreport.com/device/K960534
Methodology: https://510kreport.com/methodology