# K061954: Artelon CMC Spacer Arthro

- Pathway: 510(k) (Special)
- Applicant: Artimplant AB
- Decided: Jun 1, 2007 after 325 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: 2 generations back to K964381 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040070: Artelon Spacer CMC-1, Artimplant AB (2004) Summary page 1.

## Indications for use
Artelon® CMC Spacer Arthro intended to be implanted into the first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis.

Source page: https://510kreport.com/device/K061954
Methodology: https://510kreport.com/methodology