# K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

- Pathway: 510(k) (Traditional)
- Applicant: Tenon Medical, Inc.
- Decided: Jun 13, 2018 after 76 days
- Product code: OUR (Sacroiliac Joint Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K841189 (1984). 122 ancestors in all.
30 later devices descend from it; 11 cite it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems, Medtronic Sofamor Danek (2016) Summary page 5.
- K110472: SI-Fix Sacroiliac Joint Fusion System, Medtronic Sofamor Danek (2012) Summary page 5.
- K131405: Ifuse Implant System, SI-BONE, Inc. (2013) Summary page 5.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.

## Most influential descendants
- K221047: SILO TFX MIS Sacroiliac Joint Fixation System (2022), 9 descendants of its own
- K211496: TransLoc 3D (2022), 7 descendants of its own
- K231689: iFuse TORQ® Implant System (2023), 5 descendants of its own
- K241574: iFuse TORQ® Implant System (2024), 4 descendants of its own
- K230857: TiLink-P SI Joint Fusion System (2023), 4 descendants of its own

## Indications for use
The Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K180818
Methodology: https://510kreport.com/methodology