# K964472: Riopro Cobalt Trapeziometarcarpal Resurfacing Component

- Pathway: 510(k) (Traditional)
- Applicant: Biologically Oriented Prostheses
- Decided: Feb 3, 1997 after 88 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
Longest line of descent: 1 generation back to K864488 (1987). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864488: Swanson Titanium Condylar Implant, Dow Corning Wright (1987) Summary page 1.

## Most influential descendants
- K041451: Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 (2004), 8 descendants of its own
- K061451: Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (2006), 5 descendants of its own
- K042690: Ascension Pyrosphere (PCS) (2004), 3 descendants of its own
- K080997: Ascension Pyrocarbon Lunate (2008), 2 descendants of its own
- K111068: Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5 (2011), 1 descendant of its own

## Indications for use
The BIOPRO Cobalt Trapeziometacarpal Replacement is intended to resurface the joint in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis, or post fracture deformation or bone loss which present themselves as either a painful, instable thumb or a thumb with limited range of motion.

Source page: https://510kreport.com/device/K964472
Methodology: https://510kreport.com/methodology