# K061451: Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Aug 11, 2006 after 78 days
- Product code: KYI (Prosthesis, Wrist, Carpal Trapezium)
- Device class: 2
- Regulation: 21 CFR 888.3770
- 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: 3 generations back to K864488 (1987). 4 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- 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
- K201072: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (2020), 0 descendants of its own
- K112278: Ascension Nugrip CMC Implant (2011), 0 descendants of its own

## Recalls of this device
- Jun 3, 2013 · Class III · Z-1568-2013: As a result of a quality review, labelling content discrepancies were identified between the Instruction for Use (IFU) distributed in the US with the Ascension CMC and the content that is cleared by F

## Indications for use
The Ascension CMC 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. This is an uncemented prosthesis designed for press fit use only.

Source page: https://510kreport.com/device/K061451
Methodology: https://510kreport.com/methodology