# K231944: CATAMARAN SI Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Tenon Medical, Inc.
- Decided: Aug 24, 2023 after 55 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: 16 generations back to K841189 (1984). 123 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180818: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Tenon Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K250403: Catamaran SI Joint Fusion System (2025), 1 descendant of its own
- K241813: SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (2024), 1 descendant of its own
- K260477: CATAMARAN™ SI Joint Fusion System (2026), 0 descendants of its own
- K251525: SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (2025), 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.

Source page: https://510kreport.com/device/K231944
Methodology: https://510kreport.com/methodology