# K080997: Ascension Pyrocarbon Lunate

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Jun 17, 2008 after 70 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
Longest line of descent: 4 generations back to K864488 (1987). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864491: Swanson Titanium Carpal Lunate Implant, Dow Corning Wright (1987) Summary page 1.
- K061451: Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40, Ascension Orthopedics, Inc. (2006) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The Ascension® PyroCarbon Lunate is intended for replacement of the lunate bone in the proximal carpal row of the wrist in the presence of: Avascular necrosis (Kienboch's disease) Localized osteoarthritic changes Long-Standing dislocations

Source page: https://510kreport.com/device/K080997
Methodology: https://510kreport.com/methodology