SBF · Orthopedic Augmented Reality
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | SBF |
|---|---|
| Device Name | Orthopedic Augmented Reality |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252847 | NextAR Hip Platform | Medacta International S.A. | Jan 9, 2026 | SESE |
| K251639 | xvision Spine system | Augmedics, Ltd. | Oct 3, 2025 | SESE |
| K252054 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Sep 29, 2025 | SESE |
| K252530 | OptiVu Shoulder | Mr Surgical Solutions, LLC | Sep 10, 2025 | SESE |
| K251737 | NextAR(TM) Shoulder Platform | Medacta International S.A. | Sep 4, 2025 | SESE |
| K252170 | OptiVu Shoulder | Mr Surgical Solutions, LLC | Aug 8, 2025 | SESE |
| K250477 | NextAR(TM) Spine | Medacta International S.A. | Jul 31, 2025 | SESE |
| K250108 | OptiVu Shoulder | Mr Surgical Solutions, LLC | Jul 9, 2025 | SESE |
| K241525 | ExcelsiusXR | Globus Medical, Inc. | Jul 8, 2025 | SESE |
| K242569 | Mixed Reality Spine Navigation | Brainlab AG | May 16, 2025 | SESE |
| K243980 | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | Mar 21, 2025 | SESE |
| K243975 | Knee+ | Pixee Medical | Mar 20, 2025 | SESE |
| K250255 | xvision Spine system | Augmedics, Ltd. | Mar 13, 2025 | SESE |
| K243950 | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | Jan 13, 2025 | SESE |
| K243623 | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Dec 24, 2024 | SESE |
| K242271 | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Oct 30, 2024 | SESE |
| K241481 | xvision Spine System | Augmedics, Ltd. | Oct 16, 2024 | SESE |
| K241870 | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | Aug 19, 2024 | SESE |
| K233172 | NextAR Spine Platform | Medacta International S.A. | Apr 24, 2024 | SESE |
| K233899 | Knee+ | Pixee Medical | Mar 8, 2024 | SESE |
Top Applicants
- Medacta International S.A. — 10 clearances
- Augmedics, Ltd. — 6 clearances
- Pixee Medical — 5 clearances
- Surgical Theater, Inc. — 3 clearances
- Mr Surgical Solutions, LLC — 3 clearances
