# K111068: Stablyx CMC Arthroplasty Implant Model Sizes 1, 2, 3, 4, and 5

- Pathway: 510(k) (Traditional)
- Applicant: Skeletal Dynamics, LLC
- Decided: Dec 30, 2011 after 256 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). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061451: Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40, Ascension Orthopedics, Inc. (2006) Summary page 1.
- K052596: Modular Thumb Implant, Models 17065,17066,17243,17067,17199,17238,17005,17239,17006,17240,17007,17241,17500,17501,17507, Biopro, Inc. (2005) Summary page 1.

## Most influential descendants
- K201072: Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 (2020), 0 descendants of its own

## Indications for use
The Skeletal Dynamics Stablyx 0MGI Arthroplasty Implant Set 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 implant is intended for uncemented, press fit use.

Source page: https://510kreport.com/device/K111068
Methodology: https://510kreport.com/methodology