# K040070: Artelon Spacer CMC-1

- Pathway: 510(k) (Traditional)
- Applicant: Artimplant AB
- Decided: Sep 21, 2004 after 251 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: 1 generation back to K964381 (1997). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964381: Avanta Orthopaedics Trapezial Implant, Avanta Orthopaedics, Inc. (1997) Summary page 1.

## Most influential descendants
- K061956: Artelon STT Spacer (2007), 0 descendants of its own
- K061954: Artelon CMC Spacer Arthro (2007), 0 descendants of its own

## Indications for use
The Artelon Spacer CMC-I is intended to be implanted into the first carpometacarpal joint as an interpositional spacer between the trapezium and first metacarpal. The device is intended to be used in thumb disabilities because of osteoarthritis.

Source page: https://510kreport.com/device/K040070
Methodology: https://510kreport.com/methodology