# K060560: Ascension Pyrosphere CMC/TMT

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: May 5, 2006 after 64 days
- Product code: KWD (Prosthesis, Toe, Hemi-, Phalangeal)
- Device class: 2
- Regulation: 21 CFR 888.3730
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030319: Orthosphere Ceramic Spherical Implant, Wrightmedicaltechnologyinc (2003) Summary page 1.
- K042690: Ascension Pyrosphere (PCS), Ascension Orthopedics, Inc. (2004) Summary page 1.

## Recalls of this device
- Nov 6, 2014 · Class II · Z-0813-2015: Integra LifeSciences has determined that a portion of some specific lots of size 10 PyroSphere CMC and PyroSphere TMT devices are non-radiopaque.

## Indications for use
The Ascension® PyroSphereTM CMC/TMT 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. The Ascension® PyroSphereTM CMC/TMT is also intended for use in the 4 t /5 th tarsometatarsal (TMT) joint involvement where degenerative or post-traumatic arthritis presents: * decreased motion * arthritic changes and/or subluxation * unstable, stiff, or painful joints * degenerative joint disease of the midfoot associated with gout or pseudogout

Source page: https://510kreport.com/device/K060560
Methodology: https://510kreport.com/methodology