# K191100: ExcelsiusGPS Spine 1.1 Interbody Module

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jul 24, 2019 after 90 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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). 685 ancestors in all.
42 later devices descend from it; 11 cite it directly.
4 of 728 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 4.
- K170011: StealthStation S8 Spine Software v1.0.0, Medtronic Navigation (2017) Summary page 4.
- K163581: Navigated ELEVATE Inserter, Navigated Disc Prep Instruments, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 4.
- K130478: Sustain and Sustain Radiolucent Spacers, Globus Medical, Inc. (2013) Summary page 4.
- K102293: Caliber Spacer, Globus Medical, Inc. (2011) Summary page 4.
- K113447: Rise Spacer, Globus Medical, Inc. (2012) Summary page 4.
- K140411: Altera Spacer, Globus Medical, Inc. (2014) Summary page 4.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016) Summary page 4.

## Most influential descendants
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments (2022), 23 descendants of its own
- K211616: ExcelsiusHub (2021), 9 descendants of its own
- K241846: E3D™-C Interbody System (2024), 6 descendants of its own
- K243635: aprevo® anterior lumbar interbody fusion device with interfixation (2024), 5 descendants of its own
- K231199: Solar Lumbar Interbody Fusion System (2023), 5 descendants of its own

## Indications for use
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 and interbody fusion devices.

Source page: https://510kreport.com/device/K191100
Methodology: https://510kreport.com/methodology