# K112028: SI-Lok Sacroiliac Joint Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Dec 9, 2011 after 147 days
- Product code: HWC (Screw, Fixation, Bone)
- 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 K903810 (1990). 10 ancestors in all.
238 later devices descend from it; 16 cite it directly.
1 of 249 devices in its family (counting itself) has 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.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 1.
- K051296: Sijf Cannulated Screw System, Depuy Spine, Inc. (2005) Summary page 1.
- K111801: Simmetry (TM) Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2011). Cleared while this submission was under review Summary page 1.
- K110512: Simmetry Sacroiliac Joint Fusion System, Zyga Technology, Inc. (2011) Summary page 1.

## Most influential descendants
- K110472: SI-Fix Sacroiliac Joint Fusion System (2012), 92 descendants of its own
- K152681: iFuse Implant System (R) (2016), 84 descendants of its own
- K160652: iFUSE Implant System (2016), 83 descendants of its own
- K162733: iFuse Implant System® - iFuse-3D implant (2017), 82 descendants of its own
- K161210: RIALTO (TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC (TM) Powerease (TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation (TM) and IPC (TM) Powerease (TM) Systems (2016), 79 descendants of its own

## Indications for use
The SI-LOK TM Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Source page: https://510kreport.com/device/K112028
Methodology: https://510kreport.com/methodology