# K042690: Ascension Pyrosphere (PCS)

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Nov 13, 2004 after 45 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: 3 generations back to K864488 (1987). 4 ancestors in all.
3 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)
- K960659: Ceramic Spherical CMC Implant (Subject to Marketing Approval), Wrightmedicaltechnologyinc (1997) Summary page 1.
- K041451: Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50, Ascension Orthopedics, Inc. (2004) 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
- K060560: Ascension Pyrosphere CMC/TMT (2006), 0 descendants of its own

## Indications for use
The Ascension® PyroSphere® is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

Source page: https://510kreport.com/device/K042690
Methodology: https://510kreport.com/methodology