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/productcode/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 42)

Showing 20 most recent of 42 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253805](/device/K253805.md) | Knee+ | Pixee Medical S.A.S. | Apr 24, 2026 | SESE |
| [K252847](/device/K252847.md) | NextAR Hip Platform | Medacta International S.A. | Jan 9, 2026 | SESE |
| [K251639](/device/K251639.md) | xvision Spine system | Augmedics, Ltd. | Oct 3, 2025 | SESE |
| [K252054](/device/K252054.md) | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Sep 29, 2025 | SESE |
| [K252530](/device/K252530.md) | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | Sep 10, 2025 | SESE |
| [K251737](/device/K251737.md) | NextAR(TM) Shoulder Platform | Medacta International S.A. | Sep 4, 2025 | SESE |
| [K252170](/device/K252170.md) | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | Aug 8, 2025 | SESE |
| [K250477](/device/K250477.md) | NextAR(TM) Spine | Medacta International S.A. | Jul 31, 2025 | SESE |
| [K250108](/device/K250108.md) | OptiVu™ Shoulder | Mr Surgical Solutions, LLC | Jul 9, 2025 | SESE |
| [K241525](/device/K241525.md) | ExcelsiusXR™ | Globus Medical, Inc. | Jul 8, 2025 | SESE |
| [K242569](/device/K242569.md) | Mixed Reality Spine Navigation | Brainlab AG | May 16, 2025 | SESE |
| [K243980](/device/K243980.md) | ARVIS Surgical Navigation System | Kico Knee Innovation Company Pty Limited | Mar 21, 2025 | SESE |
| [K243975](/device/K243975.md) | Knee+ | Pixee Medical | Mar 20, 2025 | SESE |
| [K250255](/device/K250255.md) | xvision Spine system | Augmedics, Ltd. | Mar 13, 2025 | SESE |
| [K243950](/device/K243950.md) | ARVIS® Shoulder | Kico Knee Innovation Company Pty, Ltd. | Jan 13, 2025 | SESE |
| [K243623](/device/K243623.md) | SpineAR SNAP (SyncAR Spine) | Surgical Theater, Inc. | Dec 24, 2024 | SESE |
| [K242271](/device/K242271.md) | Caduceus S | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | Oct 30, 2024 | SESE |
| [K241481](/device/K241481.md) | xvision Spine System | Augmedics, Ltd. | Oct 16, 2024 | SESE |
| [K241870](/device/K241870.md) | OnPoint Augmented Reality Spine System | Onpoint Surgical, Inc. | Aug 19, 2024 | SESE |
| [K233172](/device/K233172.md) | NextAR™ Spine Platform | Medacta International S.A. | Apr 24, 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

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**Source:** [https://fda.innolitics.com/productcode/SBF](https://fda.innolitics.com/productcode/SBF)

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