# K250599: ExcelsiusGPS™ Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Nov 5, 2025 after 250 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: 26 generations back to K841189 (1984). 944 ancestors in all.
No later device cites it as a predicate yet.
6 of 945 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module, Globus Medical, Inc. (2019) Summary page 5.
- K211616: ExcelsiusHub, Globus Medical, Inc. (2021) Summary page 5.
- K222270: HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments, Globus Medical, Inc. (2022) Summary page 5.
- K201692: NuVasive Modulus XLIF Interbody System, Nu Vasive, Incorporated (2020) Summary page 5.
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 5.
- K200953: NuVasive® Cohere® Thoracolumbar Interbody System, Nu Vasive, Incorporated (2020) Summary page 5.
- K172341: NuVasive® Modulus TLIF Interbody System, Nu Vasive, Incorporated (2017) Summary page 5.
- K193541: NuVasive Cohere Thoracolumbar Interbody System, Nu Vasive, Incorporated (2020) Summary page 5.
- K161379: ELSA Spacers, Globus Medical, Inc. (2016) Summary page 5.
- K203278: INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers, Globus Medical, Inc. (2021) Summary page 5.

## Indications for use
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. ExcelsiusHub™ is intended for use as an aid for precisely locating anatomical structures to be used by surgeons for navigating 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/K250599
Methodology: https://510kreport.com/methodology