# K112278: Ascension Nugrip CMC Implant

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedic
- Decided: Nov 4, 2011 after 87 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: 4 generations back to K864488 (1987). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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.
- K061451: Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40, Ascension Orthopedics, Inc. (2006) Summary page 1.

## Indications for use
The Ascension® NuGrip® CMVC Implant 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/K112278
Methodology: https://510kreport.com/methodology