# Tenon Medical

- Location (FDA's records): Los Gatos, CA
- FDA decisions: 4 (2018–2026): 4 510(k) clearances
- Names in FDA's records: Tenon Medical (2); Tenon Medical, Inc. (2)
- Product codes: OUR (4)
- 510(k) review time since 2016: median 55 days, against 90 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 11 (6 its own); citations of its devices by later devices: 15 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- SI-BONE, Inc.: 2 (https://510kreport.com/company/si-bone)
- Medtronic Sofamor Danek: 2 (https://510kreport.com/company/medtronic-sofamor-danek)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)

## Firms that cite its devices most
- Si-Technology, LLC: 2 (https://510kreport.com/company/si-technology)
- Vgi Medical, Inc.: 1 (https://510kreport.com/company/vgi-medical)
- SurGenTec, LLC: 1 (https://510kreport.com/company/surgentec)
- Ilion Medical, Inc.: 1 (https://510kreport.com/company/ilion-medical)
- Camber Spine Technologies: 1 (https://510kreport.com/company/camber-spine-technologies)
- Foundation Fusion Solutions, LLC (Dba Cornerloc): 1 (https://510kreport.com/company/foundation-fusion-solutions-dba-cornerloc)
- Aurora Spine, Inc.: 1 (https://510kreport.com/company/aurora-spine)
- SI-BONE, Inc.: 1 (https://510kreport.com/company/si-bone)

## Its most-cited devices
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (2018), cited by 11
- K231944: CATAMARAN SI Joint Fusion System (2023), cited by 3
- K250403: Catamaran SI Joint Fusion System (2025), cited by 1

## Recent decisions
- K260477: CATAMARAN™ SI Joint Fusion System (Apr 8, 2026)
- K250403: Catamaran SI Joint Fusion System (Mar 21, 2025)
- K231944: CATAMARAN SI Joint Fusion System (Aug 24, 2023)
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (Jun 13, 2018)

Source page: https://510kreport.com/company/tenon-medical