SBF
- Product code
- SBF
- Device name
- Orthopedic Augmented Reality
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.4560
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 43
FDA classification definition
An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as augmented reality stereoscopic images to intraoperatively augment the users field of view.
510(k) clearances, last 3 years (24)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261854 | 2026-07-31 | Augmedics, Ltd. | xvision Spine system | FDA |
| K253805 | 2026-04-24 | Pixee Medical S.A.S. | Knee+ | FDA |
| K252847 | 2026-01-09 | Medacta International S.A. | NextAR Hip Platform | |
| K251639 | 2025-10-03 | Augmedics, Ltd. | xvision Spine system | |
| K252054 | 2025-09-29 | Surgical Theater, Inc. | SpineAR SNAP (SyncAR Spine) | |
| K252530 | 2025-09-10 | Mr Surgical Solutions, LLC | OptiVu Shoulder | FDA |
| K251737 | 2025-09-04 | Medacta International S.A. | NextAR(TM) Shoulder Platform | |
| K252170 | 2025-08-08 | Mr Surgical Solutions, LLC | OptiVu Shoulder | |
| K250477 | 2025-07-31 | Medacta International S.A. | NextAR(TM) Spine | |
| K250108 | 2025-07-09 | Mr Surgical Solutions, LLC | OptiVu Shoulder | FDA |
| K241525 | 2025-07-08 | Globus Medical, Inc. | ExcelsiusXR | |
| K242569 | 2025-05-16 | Brainlab AG | Mixed Reality Spine Navigation | |
| K243980 | 2025-03-21 | Kico Knee Innovation Company Pty Limit | ARVIS Surgical Navigation System | |
| K243975 | 2025-03-20 | Pixee Medical | Knee+ | |
| K250255 | 2025-03-13 | Augmedics, Ltd. | xvision Spine system | |
| K243950 | 2025-01-13 | Kico Knee Innovation Company Pty, Ltd. | ARVIS® Shoulder | |
| K243623 | 2024-12-24 | Surgical Theater, Inc. | SpineAR SNAP (SyncAR Spine) | |
| K242271 | 2024-10-30 | Taiwan Main Orthopaedic Biotechnology | Caduceus S | |
| K241481 | 2024-10-16 | Augmedics, Ltd. | xvision Spine System | |
| K241870 | 2024-08-19 | Onpoint Surgical, Inc. | OnPoint Augmented Reality Spine System | |
| K233172 | 2024-04-24 | Medacta International S.A. | NextAR Spine Platform | |
| K233899 | 2024-03-08 | Pixee Medical | Knee+ | FDA |
| K232176 | 2023-11-02 | Polarisar, Inc. | STELLAR Knee | |
| K232280 | 2023-10-29 | Medacta International S.A. | NextAR TSA Platform |
Official FDA classification page: SBF
Classification and pathway per current FDA publications. Data from openFDA (CC0).