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 |
|---|---|---|---|
| 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 |
| K220905 | xvision Spine System | Augmedics, Ltd. | 2022-11-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850084604010 | OptiVu Shoulder Pin Inserter | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604003 | OptiVu Shoulder Adapter Handle | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604126 | OptiVu Shoulder Scapula Anchor Pin | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604119 | OptiVu Shoulder Tracker Kit | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604102 | OptiVu Shoulder Humeral Gauge | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604096 | OptiVu Shoulder Software Application | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604089 | OptiVu Shoulder Sterile Tray | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604072 | OptiVu Shoulder Scapular Reference Rod | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604065 | OptiVu Shoulder Humeral Reference Rod | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604058 | OptiVu Shoulder Clocking Guide | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604041 | OptiVu Shoulder Reaming Guide | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604034 | OptiVu Shoulder Stylus | MR Surgical Solutions LLC | 2026-06-03 |
| 00850084604027 | OptiVu Shoulder Cut Guide | MR Surgical Solutions LLC | 2026-06-03 |
| 03760297030490 | KneePlus | PIXEE MEDICAL | 2026-05-27 |
| 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 |