# K171651: Excelsius GPS

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Aug 16, 2017 after 72 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K040583 (2004). 426 ancestors in all.
69 later devices descend from it; 28 cite it directly.
2 of 496 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133444: Stealthstation S7 / I7 / Fusion Navigation Systems, Axiem Navigation System, Medtronic Navigation, Inc. (2014) Summary page 4.
- K151511: ROSA Spine, Medtech S.A (2016) Summary page 4.
- K143633: CREO Stabilization System, Globus Medical, Inc. (2015) Summary page 4.
- K133350: Revere Stabilization System, Globus Medical, Inc. (2014) Summary page 4.
- K111449: Revolve Additional Implants, Globus Medical, Inc. (2011) Summary page 4.
- K161591: QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments, Globus Medical, Inc. (2016) Summary page 4.
- K123783: Ellipse Occipito-Cerico-Thoracic Spinal System and Capitol Implants, Globus Medical, Inc. (2013) Summary page 4.
- K112028: SI-Lok Sacroiliac Joint Fixation System, Globus Medical, Inc. (2011) Summary page 4.
- K162825: CAPTIVATE™ Compression Screws, Globus Medical, Inc. (2017) Summary page 4.

## Most influential descendants
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own
- 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
- K220862: E-GPS Navigated Instruments (2022), 7 descendants of its own
- K241846: E3D™-C Interbody System (2024), 6 descendants of its own

## Recalls of this device
- Dec 15, 2023 · Class II · Z-1007-2024: Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infect

## Indications for use
The EXCELSIUS GPS™ 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/K171651
Methodology: https://510kreport.com/methodology