# K210912: Excelsius3D

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Aug 12, 2021 after 136 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K003266 (2000). 10 ancestors in all.
10 later devices descend from it; 1 cites it directly.
2 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092564: O-Arm Imaging System, Medtronic Navigation, Inc. (Littleton) (2010) Summary page 4.
- K200074: O-arm O2 Imaging System, Medtronic, Inc. (2020) Summary page 4.

## Most influential descendants
- K211616: ExcelsiusHub (2021), 9 descendants of its own
- 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

## Indications for use
Excelsius3D™ is a mobile X-ray system designed for 2D fluoroscopy, 2D digital radiography, and 3D imaging of adult and pediatric patients. The system is indicated for use where a physician benefits from 2D and 3D information on anatomic structures and high contrast objects with high x-ray attenuation such as bony anatomy and metallic objects. Excelsius3D™ images are compatible with image guided systems such as ExcelsiusGPS®.

Source page: https://510kreport.com/device/K210912
Methodology: https://510kreport.com/methodology