# K080398: SI Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: SI-BONE, Inc.
- Decided: Nov 26, 2008 after 287 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: 2 generations back to K930834 (1993). 9 ancestors in all.
144 later devices descend from it; 11 cite it directly.
0 of 154 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 1.
- K051309: Roi Fusion Rods & Plates, Reiley Orthopaedics, Inc. (2005) Summary page 1.
- K051296: Sijf Cannulated Screw System, Depuy Spine, Inc. (2005) Summary page 1.

## Most influential descendants
- K110838: Ifuse Implant System (2011), 143 descendants of its own
- K122074: Ifuse Implant System (2012), 139 descendants of its own
- K123850: Ifuse Implant System (2013), 134 descendants of its own
- K131405: Ifuse Implant System (2013), 133 descendants of its own
- K110472: SI-Fix Sacroiliac Joint Fusion System (2012), 92 descendants of its own

## Indications for use
The SI-Bone Si Joint Fusion system is intended for fracture fixation of large bones and large bone fragments of the pelvis for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K080398
Methodology: https://510kreport.com/methodology