# K092375: Modification to SI Joint Fusion System

- Pathway: 510(k) (Special)
- Applicant: SI-BONE, Inc.
- Decided: Sep 4, 2009 after 30 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
No predicates in its family tree.
255 later devices descend from it; 14 cite it directly.
1 of 256 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SI-Bone, Inc.’s SI Joint Fusion System: named in the summary without a submission number

## Most influential descendants
- K102907: Simmetry Sacroiliac Joint Fusion System (2010), 245 descendants of its own
- K110512: Simmetry Sacroiliac Joint Fusion System (2011), 241 descendants of its own
- K111801: Simmetry (TM) Sacroiliac Joint Fusion System (2011), 240 descendants of its own
- K112028: SI-Lok Sacroiliac Joint Fixation System (2011), 238 descendants of its own
- K110838: Ifuse Implant System (2011), 143 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/K092375
Methodology: https://510kreport.com/methodology