# K201072: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161

- Pathway: 510(k) (Traditional)
- Applicant: Ensemble Orthopedics, LLC
- Decided: Dec 2, 2020 after 224 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: 6 generations back to K864488 (1987). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042690: Ascension Pyrosphere (PCS), Ascension Orthopedics, Inc. (2004) Summary page 4.
- K061451: Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40, Ascension Orthopedics, Inc. (2006) Summary page 4.
- K092548: Extremity Medical Trapezium Prosthesis, Extremity Medical, LLC (2009) Summary page 4.
- K111068: Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5, Skeletal Dynamics, LLC (2011) Summary page 4.
- K033529: Tie-in Trapezium, Wrightmedicaltechnologyinc (2003) Summary page 4.

## Indications for use
The Ensemble CMC 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 of bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.

Source page: https://510kreport.com/device/K201072
Methodology: https://510kreport.com/methodology