# K864491: Swanson Titanium Carpal Lunate Implant

- Pathway: 510(k) (Traditional)
- Applicant: Dow Corning Wright
- Decided: Apr 15, 1987 after 153 days
- Product code: KWN (Prosthesis, Wrist, Carpal Lunate)
- Device class: 2
- Regulation: 21 CFR 888.3750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K050028: Maestro Carpal Hemiarthroplasty (2005), 3 descendants of its own
- K080997: Ascension Pyrocarbon Lunate (2008), 2 descendants of its own
- K141920: Wrist Hemiarthroplasty System (2014), 1 descendant of its own
- K092548: Extremity Medical Trapezium Prosthesis (2009), 1 descendant of its own
- K201072: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K864491
Methodology: https://510kreport.com/methodology