# K250403: Catamaran SI Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: Tenon Medical
- Decided: Mar 21, 2025 after 37 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: 17 generations back to K841189 (1984). 134 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231944: CATAMARAN SI Joint Fusion System, Tenon Medical, Inc. (2023) Summary page 5.
- K193524: SI-BONE iFuse Implant System®, SI-BONE, Inc. (2020) Summary page 5.
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Tenon Medical, Inc. (2018) Summary page 6.

## Most influential descendants
- K260477: CATAMARAN™ SI Joint Fusion System (2026), 0 descendants of its own

## Indications for use
The Tenon Medical Catamaran SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including: Sacroiliac joint disruptions and degenerative sacroiliitis To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.

Source page: https://510kreport.com/device/K250403
Methodology: https://510kreport.com/methodology