# K061956: Artelon STT Spacer

- Pathway: 510(k) (Traditional)
- Applicant: Artimplant AB
- Decided: Jun 7, 2007 after 331 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.
- (no number) Swanson Trapezium Implant: named in the summary without a submission number

## Indications for use
ARTELON STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezial-trapezioid bones. The device is intended to be used in thumb disabilities caused by osteoarthritis.

Source page: https://510kreport.com/device/K061956
Methodology: https://510kreport.com/methodology