SBF
43 FDA 510(k) clearances · Product code
111 daysmedian time to decision
261 days90th percentile
43clearances measured
FDA profile
- Official device name
- Orthopedic Augmented Reality
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Medical specialty
- Neurology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| xvision Spine system (K261854) | Augmedics, Ltd. | 2026-07-31 |
| Knee+ (K253805) | Pixee Medical S.A.S. | 2026-04-24 |
| NextAR Hip Platform (K252847) | Medacta International S.A. | 2026-01-09 |
| xvision Spine system (K251639) | Augmedics, Ltd. | 2025-10-03 |
| SpineAR SNAP (SyncAR Spine) (K252054) | Surgical Theater, Inc. | 2025-09-29 |
| OptiVu™ Shoulder (K252530) | Mr Surgical Solutions, LLC | 2025-09-10 |
| NextAR(TM) Shoulder Platform (K251737) | Medacta International S.A. | 2025-09-04 |
| OptiVu™ Shoulder (K252170) | Mr Surgical Solutions, LLC | 2025-08-08 |
| NextAR(TM) Spine (K250477) | Medacta International S.A. | 2025-07-31 |
| OptiVu™ Shoulder (K250108) | Mr Surgical Solutions, LLC | 2025-07-09 |
| ExcelsiusXR™ (K241525) | Globus Medical, Inc. | 2025-07-08 |
| Mixed Reality Spine Navigation (K242569) | Brainlab AG | 2025-05-16 |
| ARVIS Surgical Navigation System (K243980) | Kico Knee Innovation Company Pty Limited | 2025-03-21 |
| Knee+ (K243975) | Pixee Medical | 2025-03-20 |
| xvision Spine system (K250255) | Augmedics, Ltd. | 2025-03-13 |
| ARVIS® Shoulder (K243950) | Kico Knee Innovation Company Pty, Ltd. | 2025-01-13 |
| SpineAR SNAP (SyncAR Spine) (K243623) | Surgical Theater, Inc. | 2024-12-24 |
| Caduceus S (K242271) | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2024-10-30 |
| xvision Spine System (K241481) | Augmedics, Ltd. | 2024-10-16 |
| OnPoint Augmented Reality Spine System (K241870) | Onpoint Surgical, Inc. | 2024-08-19 |
| NextAR™ Spine Platform (K233172) | Medacta International S.A. | 2024-04-24 |
| Knee+ (K233899) | Pixee Medical | 2024-03-08 |
| STELLAR Knee (K232176) | Polarisar, Inc. | 2023-11-02 |
| NextAR™ TSA Platform (K232280) | Medacta International S.A. | 2023-10-29 |
| OnPoint Augmented Reality Spine System (K231284) | Onpoint Surgical, Inc. | 2023-09-08 |
| HOLO Portal™ Surgical Guidance System (K231611) | Surgalign Spine Technologies | 2023-08-31 |
| NextAR™ Spine Platform (K223769) | Medacta International S.A. | 2023-07-21 |
| OptiVu™ ROSA® MxR (K230567) | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-06-13 |
| Knee+ (K230789) | Pixee Medical | 2023-04-21 |
| Caduceus S (K220554) | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2022-12-16 |
| xvision Spine System (K220905) | Augmedics, Ltd. | 2022-11-17 |
| SpineAR SNAP (K213034) | Surgical Theater, Inc. | 2022-09-29 |
| Knee+ (K220104) | Pixee Medical | 2022-09-01 |
| OptiVu ROSA MxR (K220733) | Orthosoft Inc (D/B/A Zimmer Cas) | 2022-07-29 |
| NextAR™ TKA Platform My Knee PPS (K213751) | Medacta International S.A. | 2022-03-10 |
| ARAI Surgical Navigation System (K211254) | Surgalign Spine Technologies | 2022-01-14 |
| NextAR™ Spine Platform (K210859) | Medacta International S.A. | 2021-11-05 |
| xvision Spine system (XVS) (K211188) | Augmedics, Ltd. | 2021-07-19 |
| NextAR RSA Platform (K210153) | Medacta International S.A. | 2021-05-12 |
| Knee+ (K202750) | Pixee Medical | 2021-04-21 |
| NextAR TKA Platform (K202152) | Medacta International S.A. | 2020-10-27 |
| NextAR TKA Platform (K193559) | Medacta Inernational SA | 2020-07-10 |
| xvision Spine system (XVS) (K190929) | Augmedics, Ltd. | 2019-12-20 |
Track SBF automatically
Every clearance here is in the API, with alerts when new ones post.