# K183119: SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Feb 6, 2019 after 89 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: 19 generations back to K040583 (2004). 472 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 475 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011) Summary page 6.
- K962011: Synthes 7.0/7.3 MM Cannulated Screws, Synthes (Usa) (1996) Summary page 6.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 6.
- 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, Medtronic Sofamor Danek (2016) Summary page 6.
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 7.
- K153203: Navigation Instruments, Globus Medical, Inc. (2016) Summary page 7.
- K180690: Navigation Instruments, Globus Medical, Inc. (2018) Summary page 7.

## Most influential descendants
- K231923: Liberty SI Lateral Implant System (2023), 0 descendants of its own
- K212962: TRELLIS™ SI Joint Fusion System (2022), 0 descendants of its own

## Indications for use
The SI-LOK® Sacroiliac Joint Fixation System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. Globus Navigation Instruments are intended to be used during the preparation and placement of Globus screws (QUARTEX®, CREO®, REVERE®, REVOLVE®, ELLIPSE®, PROTEX® CT, and SI-LOK®) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MRI based model, fluoroscopy images, or digitized landmarks of the anatomy. The ExcelsiusGPS® is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy. The system is indicated for the placement of spinal and orthopedic bone screws.

Source page: https://510kreport.com/device/K183119
Methodology: https://510kreport.com/methodology