# K200047: ExcelsiusGPS Cranial 1.0 Module

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jul 10, 2020 after 183 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K040583 (2004). 690 ancestors in all.
5 later devices descend from it; 2 cite it directly.
7 of 696 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.
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module, Globus Medical, Inc. (2019) Summary page 4.
- K162309: StealthStation S8 System Platforms and StealthStation Cranial Software, Medtronic Navigation, Inc. (2017) Summary page 4.
- K182417: ROSA ONE Brain Application, Medtech S.A (2019) Summary page 4.

## Most influential descendants
- K231850: QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments (2024), 2 descendants of its own
- K252327: CMORE® CT System; CMORE® CT System Navigated Instruments (2025), 1 descendant of its own
- K203153: CREO Stabilization System, Navigation Instruments, ExcelsiusGPS (2021), 1 descendant of its own
- K253739: SCRIPT™ Rods, CREO™ Stabilization System,  REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System (2026), 0 descendants of its own
- K254045: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (2026), 0 descendants of its own

## Recalls of this device
- Dec 11, 2023 · Class II · Z-0995-2024: Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
- Dec 11, 2023 · Class II · Z-0996-2024: Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
- Dec 11, 2023 · Class II · Z-0997-2024: Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.

## Indications for use
The ExcelsiusGPS is intended for use as an aid for precisely locating anatomical structures and for 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 spacers, and intracranial devices including biopsy needles, electrodes, and tubes.

Source page: https://510kreport.com/device/K200047
Methodology: https://510kreport.com/methodology