# K061089: Modular Thumb Implant, Models 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Jun 20, 2006 after 63 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1. Rheumatoid arthritis 2. Traumatic arthritis 3. Osteoarthritis 4. Post Fracture deformation or bone loss

Source page: https://510kreport.com/device/K061089
Methodology: https://510kreport.com/methodology