# K150017: SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System

- Pathway: 510(k) (Traditional)
- Applicant: Spinefrontier, Inc.
- Decided: Apr 24, 2015 after 109 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: 5 generations back to K930834 (1993). 13 ancestors in all.
14 later devices descend from it; 4 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)
- K122074: Ifuse Implant System, SI-BONE, Inc. (2012) Summary page 5.

## Most influential descendants
- K231689: iFuse TORQ® Implant System (2023), 5 descendants of its own
- K241574: iFuse TORQ® Implant System (2024), 4 descendants of its own
- K230446: TiLink-L SI Joint Fusion System (2023), 3 descendants of its own
- K231829: Xenix Medical Sacroiliac Fixation System (2023), 2 descendants of its own
- K231831: TiLink-L Joint Fusion System (2023), 2 descendants of its own

## Indications for use
The SIJFuse™ Sacroiliac Joint Fusion Device System is intended for fusion of the sacroiliac joint for conditions including sacroiliac joint disruptions and degenerative sacroilitis.

Source page: https://510kreport.com/device/K150017
Methodology: https://510kreport.com/methodology