# K241525: ExcelsiusXR™

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Jul 8, 2025 after 404 days
- Product code: SBF (Orthopedic Augmented Reality)
- 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: 21 generations back to K040583 (2004). 701 ancestors in all.
No later device cites it as a predicate yet.
5 of 702 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220905: xvision Spine System, Augmedics, Ltd. (2022) Summary page 5.
- K211616: ExcelsiusHub, Globus Medical, Inc. (2021) Summary page 5.
- K171651: Excelsius GPS, Globus Medical, Inc. (2017) Summary page 5.
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module, Globus Medical, Inc. (2019) Summary page 5.

## Indications for use
ExcelsiusXR™, when used in conjunction with ExcelsiusHub™ and/or ExcelsiusGPS®, is intended for use as an aid for precisely locating anatomical structures 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. This system is indicated for the placement of spinal and orthopedic (Sacroiliac, Ulna, and Tibia) bone screws, and interbody fusion devices. The ExcelsiusXR™ Headset displays 2D stereotactic images and 3D virtual anatomy images, and displays the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. This headset should not be relied upon solely for absolute positional information and should always be used in conjunction with the primary stereotactic display.

Source page: https://510kreport.com/device/K241525
Methodology: https://510kreport.com/methodology