Product code SBF
- Device name
- Orthopedic Augmented Reality
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4560
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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 user’s field of view.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261854 | xvision Spine system | Augmedics, Ltd. | 2026-07-31 |
| K253805 | Knee+ | Pixee Medical S.A.S. | 2026-04-24 |
| K252847 | NextAR Hip Platform | Medacta International S.A. | 2026-01-09 |
| K251639 | xvision Spine system | Augmedics, Ltd. | 2025-10-03 |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2025-09-29 |
| K252530 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025-09-10 |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. | 2025-09-04 |
| K252170 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025-08-08 |
| K250477 | NextAR(TM) Spine | Medacta International S.A. | 2025-07-31 |
| K250108 | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | 2025-07-09 |
| K241525 | ExcelsiusXR™ | Globus Medical, Inc. | 2025-07-08 |
| K242569 | Mixed Reality Spine Navigation | Brainlab AG | 2025-05-16 |
| K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | 2025-03-21 |
| K243975 | Knee+ | Pixee Medical | 2025-03-20 |
| K250255 | xvision Spine system | Augmedics, Ltd. | 2025-03-13 |
| K243950 | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | 2025-01-13 |
| K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | 2024-12-24 |
| K242271 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2024-10-30 |
| K241481 | xvision Spine System | Augmedics, Ltd. | 2024-10-16 |
| K241870 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | 2024-08-19 |
| K233172 | NextAR™ Spine Platform | Medacta International S.A. | 2024-04-24 |
| K233899 | Knee+ | Pixee Medical | 2024-03-08 |
| K232176 | STELLAR Knee | Polarisar, Inc. | 2023-11-02 |
| K232280 | NextAR™ TSA Platform | Medacta International S.A. | 2023-10-29 |
| K231284 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | 2023-09-08 |
| K231611 | HOLO Portal™ Surgical Guidance System | Surgalign Spine Technologies | 2023-08-31 |
| K223769 | NextAR™ Spine Platform | Medacta International S.A. | 2023-07-21 |
| K230567 | OptiVu™ ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-06-13 |
| K230789 | Knee+ | Pixee Medical | 2023-04-21 |
| K220554 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2022-12-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04056481146672 | Mixed Reality Spine Navigation | Brainlab SE | 2025-07-31 |
| 00810180350013 | ARVIS ® | KICO KNEE INNOVATION COMPANY PTY LIMITED | 2025-07-29 |
| 04056481143985 | Mixed Reality Spine Navigation | Brainlab SE | 2025-05-31 |
| 07630345709899 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709882 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709875 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709868 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709851 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709844 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709837 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709820 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709813 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709806 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709790 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709783 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709776 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709769 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709752 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709745 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709738 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709721 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709714 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709707 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709691 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709684 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709677 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709660 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709653 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345709646 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |
| 07630345701541 | NextAR Spine Platform | Medacta International SA | 2021-12-07 |