# K864488: Swanson Titanium Condylar Implant

- Pathway: 510(k) (Traditional)
- Applicant: Dow Corning Wright
- Decided: Apr 15, 1987 after 153 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.
11 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964472: Riopro Cobalt Trapeziometarcarpal Resurfacing Component (1997), 9 descendants of its own
- 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

Source page: https://510kreport.com/device/K864488
Methodology: https://510kreport.com/methodology
