# K140079: Silex Sacroiliac Joint Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: X-Spine Systems, Inc.
- Decided: Mar 25, 2014 after 71 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). 26 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123702: Silex Sacroiliac Joint Fusion System, X-Spine Systems, Inc. (2013) Summary page 2.
- K131405: Ifuse Implant System, SI-BONE, Inc. (2013) Summary page 2.
- K130092: Simmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2013) Summary page 2.
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011) Summary page 2.
- K110472: SI-Fix Sacroiliac Joint Fusion System, Medtronic Sofamor Danek (2012) Summary page 2.

## Most influential descendants
- K152237: The Entasis Dual-Lead Sacroiliac Implant (2016), 11 descendants of its own
- K223708: Entasis 3D Dual-Lead Sacroiliac Implant System (2023), 3 descendants of its own
- K223521: ZESPIN SI Joint Fusion System (2023), 2 descendants of its own
- K240505: Eminent Spine SI Screw System (2024), 1 descendant of its own
- K231841: PathLoc SI Joint Fusion System (2023), 1 descendant of its own

## Indications for use
The Silex 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/K140079
Methodology: https://510kreport.com/methodology