# K965204: Avanta Orthopaedics Trapezium Implant

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Jun 3, 1997 after 159 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Dow Corning Corporation Silastic Swanson Trapezium Implant: named in the summary without a submission number

## Indications for use
Avanta Orthopaedics Trapezium Implant may be considered for use in thumb disabilities because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis as follows: Localized pain and palpable crepitation during circumduction movements with axial compression of the thumb. Loss of the thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint, trapeziotrapezoid and trapezium second metacarpal joint, singly or in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity. Following an old Bennet fracture.

Source page: https://510kreport.com/device/K965204
Methodology: https://510kreport.com/methodology