# K041451: Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Aug 25, 2004 after 85 days
- Product code: KYI (Prosthesis, Wrist, Carpal Trapezium)
- Device class: 2
- Regulation: 21 CFR 888.3770
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K864488 (1987). 3 ancestors in all.
8 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)
- K864488: Swanson Titanium Condylar Implant, Dow Corning Wright (1987) Summary page 1.
- K960659: Ceramic Spherical CMC Implant (Subject to Marketing Approval), Wrightmedicaltechnologyinc (1997) Summary page 1.
- K964472: Riopro Cobalt Trapeziometarcarpal Resurfacing Component, Biologically Oriented Prostheses (1997) Summary page 1.

## Most influential descendants
- 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
- K111068: Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5 (2011), 1 descendant of its own
- K092548: Extremity Medical Trapezium Prosthesis (2009), 1 descendant of its own

## Recalls of this device
- Jul 12, 2010 · Not classified · Z-0437-2011: Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
- Jul 12, 2010 · Not classified · Z-0438-2011: Two different product lots were found to be incorrectly labeled and placed into the incorrect box.

## Indications for use
The Ascension® PyroHemiSphereTM is intended to replace the proximal end of the first metacarpal 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/K041451
Methodology: https://510kreport.com/methodology