SBF — Orthopedic Augmented Reality Class II
FDA product code SBF covers "Orthopedic Augmented Reality", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SBF
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Neurology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253805 | pixee medical | Knee+ | April 24, 2026 |
| K252847 | medacta international | NextAR Hip Platform | January 9, 2026 |
| K251639 | augmedics | xvision Spine system | October 3, 2025 |
| K252054 | surgical theater | SpineAR SNAP (SyncAR Spine) | September 29, 2025 |
| K252530 | surgical solutions | OptiVu Shoulder | September 10, 2025 |
| K251737 | medacta international | NextAR(TM) Shoulder Platform | September 4, 2025 |
| K252170 | surgical solutions | OptiVu Shoulder | August 8, 2025 |
| K250477 | medacta international | NextAR(TM) Spine | July 31, 2025 |
| K250108 | surgical solutions | OptiVu Shoulder | July 9, 2025 |
| K241525 | globus medical | ExcelsiusXR | July 8, 2025 |
| K242569 | brainlab | Mixed Reality Spine Navigation | May 16, 2025 |
| K243980 | kico knee innovation company pty limited | ARVIS Surgical Navigation System | March 21, 2025 |
| K243975 | pixee medical | Knee+ | March 20, 2025 |
| K250255 | augmedics | xvision Spine system | March 13, 2025 |
| K243950 | kico knee innovation company pty | ARVIS® Shoulder | January 13, 2025 |
| K243623 | surgical theater | SpineAR SNAP (SyncAR Spine) | December 24, 2024 |
| K242271 | taiwan main orthopaedic biotechnology co | Caduceus S | October 30, 2024 |
| K241481 | augmedics | xvision Spine System | October 16, 2024 |
| K241870 | onpoint surgical | OnPoint Augmented Reality Spine System | August 19, 2024 |
| K233172 | medacta international | NextAR Spine Platform | April 24, 2024 |