# K181881: Outlet Sacroiliac Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Sij Surgical
- Decided: Oct 3, 2018 after 82 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: 7 generations back to K903810 (1990). 23 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 5.
- K110472: SI-Fix Sacroiliac Joint Fusion System, Medtronic Sofamor Danek (2012) Summary page 5.
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011) Summary page 5.
- K141549: SImmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2015) Summary page 5.

## Most influential descendants
- K214123: T-FIX® 3DSI Joint Fusion System (2022), 1 descendant of its own
- K213590: Blue Topaz Sacroiliac Screw System (2022), 1 descendant of its own
- K253611: Falco Fusion System (2026), 0 descendants of its own
- K230689: T-FIX™ 3DSI Joint Fusion System (2023), 0 descendants of its own

## Indications for use
The Outlet Sacroiliac Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K181881
Methodology: https://510kreport.com/methodology