| K-number | K241525 |
| Device name | ExcelsiusXR |
| Applicant | Globus Medical, Inc. |
| Product code | SBF |
| Device class | Class II |
| Decision date | Jul 8, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 882.4560 |
ExcelsiusXR™ is a head-mounted augmented reality navigation headset used with ExcelsiusHub and/or ExcelsiusGPS to aid surgeons in precisely locating anatomical structures and guiding surgical instruments during open or percutaneous procedures. It displays 2D stereotactic images and 3D virtual anatomy with real-time instrument tracking, indicated for spinal and orthopedic bone screw placement and interbody fusion devices. The headset projects navigation data onto the surgeon's retina via a transparent near-eye display, allowing simultaneous viewing of the patient and navigation information.
ExcelsiusXR™ incorporates integrated planning software with save/load and merge image functionality, intraoperative/preoperative CT and fluoroscopy image guidance, patient registration via registration fixtures or fluoroscopic-to-CT merge, accuracy verification on anatomical landmarks, real-time instrument position display, and hand tracking for headset manipulation. These features mirror the predicate devices' core technological approach of intraoperative image-guided navigation with similar workflow and user interface design.
IEC 60601-1:2020 (electrical safety and essential performance), IEC 60601-1-2:2020 (electromagnetic disturbances), IEC 60601-1-6:2020 (usability), IEC 62304:2015 (software lifecycle processes), and IEC 62366-1:2020 (usability engineering). Testing included non-clinical system verification, surgical phantom simulations, optical bench testing of the head-mounted display, and software verification/validation per FDA guidance with Enhanced Documentation determination.
ExcelsiusXR™ shares the same intended use, fundamental principle of operation, and technological characteristics as the predicate Augmedics xvision Spine System and ExcelsiusHub/ExcelsiusGPS devices. All three systems perform intraoperative/preoperative image-guided navigation with real-time instrument tracking, patient registration via identical methods, and manual or robotic instrument guidance in the operating room. ExcelsiusXR™ adds save/load planning and merge image functionality already present in ExcelsiusHub, and demonstrates equivalent accuracy verification and patient fixation methods, establishing substantial equivalence based on comparable technical design and performance within the same surgical navigation domain.
View the full FDA submission: accessdata.fda.gov