# K211616: ExcelsiusHub

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Aug 25, 2021 after 91 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: 1 (1 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). 697 ancestors in all.
9 later devices descend from it; 7 cite it directly.
5 of 707 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.
- K210912: Excelsius3D, Globus Medical, Inc. (2021). Cleared while this submission was under review 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
- K233638: VERZA™ High Speed Drills (2024), 1 descendant of its own
- K254045: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System (2026), 0 descendants of its own
- K250599: ExcelsiusGPS™ Instruments (2025), 0 descendants of its own

## Recalls of this device
- Dec 7, 2023 · Class I · Z-0642-2024: A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.

## Indications for use
The 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/K211616
Methodology: https://510kreport.com/methodology