# K964381: Avanta Orthopaedics Trapezial Implant

- Pathway: 510(k) (Traditional)
- Applicant: Avanta Orthopaedics, Inc.
- Decided: Jan 22, 1997 after 79 days
- Product code: KYI (Prosthesis, Wrist, Carpal Trapezium)
- Device class: 2
- Regulation: 21 CFR 888.3770
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) Dow Corning Corporation Silastic H.P. Trapezial Implant: named in the summary without a submission number

## Most influential descendants
- K040070: Artelon Spacer CMC-1 (2004), 2 descendants of its own
- K061956: Artelon STT Spacer (2007), 0 descendants of its own
- K061954: Artelon CMC Spacer Arthro (2007), 0 descendants of its own

## Recalls of this device
- Jan 24, 2003 · Not classified · Z-0710-03: Wrong silicone elastomer used in construction.

## Indications for use
The device is intended to be used in the treatment of 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 thumb motion with decrease of normal pinch and grip strength. Radiological evidence of arthritic changes of the trapeziometacarpal joint of the thumb or thumb and index finger in combination. Unstable, stiff, or painful distal joints of the thumb or swan-neck deformity.

Source page: https://510kreport.com/device/K964381
Methodology: https://510kreport.com/methodology