Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart E — Neurological Surgical Devices](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices) → [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) → SBF — Orthopedic Augmented Reality # SBF · Orthopedic Augmented Reality _Neurology · 21 CFR 882.4560 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF ## Overview - **Product Code:** SBF - **Device Name:** Orthopedic Augmented Reality - **Regulation:** [21 CFR 882.4560](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/882.4560) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## 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](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K252847.md) | NextAR Hip Platform | Medacta International S.A. | Jan 9, 2026 | SESE | | [K251639](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K251639.md) | xvision Spine system | Augmedics, Ltd. | Oct 3, 2025 | SESE | | [K252054](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K252054.md) | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Sep 29, 2025 | SESE | | [K252530](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K252530.md) | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | Sep 10, 2025 | SESE | | [K251737](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K251737.md) | NextAR(TM) Shoulder Platform | Medacta International S.A. | Sep 4, 2025 | SESE | | [K252170](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K252170.md) | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | Aug 8, 2025 | SESE | | [K250477](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K250477.md) | NextAR(TM) Spine | Medacta International S.A. | Jul 31, 2025 | SESE | | [K250108](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K250108.md) | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | Jul 9, 2025 | SESE | | [K241525](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K241525.md) | ExcelsiusXR™ | Globus Medical, Inc. | Jul 8, 2025 | SESE | | [K242569](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K242569.md) | Mixed Reality Spine Navigation | Brainlab AG | May 16, 2025 | SESE | | [K243980](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K243980.md) | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | Mar 21, 2025 | SESE | | [K243975](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K243975.md) | Knee+ | Pixee Medical | Mar 20, 2025 | SESE | | [K250255](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K250255.md) | xvision Spine system | Augmedics, Ltd. | Mar 13, 2025 | SESE | | [K243950](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K243950.md) | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | Jan 13, 2025 | SESE | | [K243623](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K243623.md) | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Dec 24, 2024 | SESE | | [K242271](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K242271.md) | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Oct 30, 2024 | SESE | | [K241481](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K241481.md) | xvision Spine System | Augmedics, Ltd. | Oct 16, 2024 | SESE | | [K241870](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K241870.md) | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | Aug 19, 2024 | SESE | | [K233172](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K233172.md) | NextAR™ Spine Platform | Medacta International S.A. | Apr 24, 2024 | SESE | | [K233899](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF/K233899.md) | Knee+ | Pixee Medical | Mar 8, 2024 | SESE | ## Top Applicants - Medacta International S.A. — 10 clearances - Augmedics, Ltd. — 6 clearances - Pixee Medical — 5 clearances - Mr Surgical Solutions, LLC — 3 clearances - Surgical Theater, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/SBF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com