# K180744: Stablyx CMC Arthroplasty Implant System

- Pathway: 510(k) (Special)
- Applicant: Skeletal Dynamics, LLC
- Decided: Apr 11, 2018 after 20 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Stablyx CMC Arthroplasty Implant System: named in the summary without a submission number

## Indications for use
The Stablyx CMC Arthroplasty Implant System 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 painful, unstable thumb or a thumb with limited range of motion. The implant is intended for uncemented, press fit use.

Source page: https://510kreport.com/device/K180744
Methodology: https://510kreport.com/methodology