# K123702: Silex Sacroiliac Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Mar 11, 2013 after 98 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: 3 generations back to K903810 (1990). 7 ancestors in all.
49 later devices descend from it; 6 cite it directly.
0 of 57 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 2.
- K102907: Simmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2010) Summary page 2.
- K092375: Modification to SI Joint Fusion System, SI-BONE, Inc. (2009) Summary page 2.

## Most influential descendants
- K191748: Genesys Spine Sacroiliac Joint Fusion System (2019), 22 descendants of its own
- K203247: iFuse-TORQ™ Implant System (2021), 17 descendants of its own
- K213667: iFuse-TORQ® Implant System (2022), 15 descendants of its own
- K222605: iFuse TORQ® Implant System (2022), 14 descendants of its own
- K153656: PathLoc-SI Joint Fusion System (2016), 13 descendants of its own

## Indications for use
The Silex Sacroiliac Joint Fusion System is intended for fixation of large bones, including bones of the pelvis, for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Source page: https://510kreport.com/device/K123702
Methodology: https://510kreport.com/methodology