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) → OLO — Orthopedic Stereotaxic Instrument

# OLO · Orthopedic Stereotaxic Instrument

_Neurology · 21 CFR 882.4560 · Class 2_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/OLO

## Overview

- **Product Code:** OLO
- **Device Name:** Orthopedic Stereotaxic Instrument
- **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 440)

Showing 20 most recent of 440 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K262506](/device/K262506.md) | Remex Spine Surgery Navigation - Universal Instruments | Remex Medical Corp. | Aug 20, 2026 | SESE |
| [K261410](/device/K261410.md) | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit)) | Suite 201, National Innovation Centre | Jul 30, 2026 | SESE |
| [K261205](/device/K261205.md) | SPINEART Navigation Instrument System | Spineart SA | Jul 29, 2026 | SESE |
| [K262121](/device/K262121.md) | Ion-L Navigated Instruments | SurGenTec, LLC | Jul 24, 2026 | SESE |
| [K261024](/device/K261024.md) | TMINI Miniature Robotic System | THINK Surgical, Inc. | Jul 24, 2026 | SESE |
| [K261113](/device/K261113.md) | Op.n™ Spine Navigation and Robotic Guidance | Ecential Robotics | Jul 22, 2026 | SESE |
| [K261852](/device/K261852.md) | OTS Hip | Ortoma AB | Jul 1, 2026 | SESE |
| [K253921](/device/K253921.md) | VERTICALE® Navigation Instruments | Silony Medical GmbH | Jun 26, 2026 | SESE |
| [K260480](/device/K260480.md) | VELYS™ Robotic-Assisted Solution | Depuy Ireland UC | Jun 25, 2026 | SESE |
| [K260369](/device/K260369.md) | Dynamis Robotic Surgical System | LEM Surgical AG | Jun 20, 2026 | SESE |
| [K261665](/device/K261665.md) | CORUS™ Navigation System-GN | Providence Medical Technology, Inc. | Jun 18, 2026 | SESE |
| [K260571](/device/K260571.md) | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | Jun 2, 2026 | SESE |
| [K261060](/device/K261060.md) | Navigated LLIF Impactable Tracker | Tyber Medical, LLC | May 29, 2026 | SESE |
| [K254157](/device/K254157.md) | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | Medos International SARL | May 26, 2026 | SESE |
| [K260329](/device/K260329.md) | Ion-C Navigation Instruments | SurGenTec, LLC | May 22, 2026 | SESE |
| [K260582](/device/K260582.md) | ROSA® Shoulder System | Orthosoft Inc. (d/b/a) Zimmer CAS | May 21, 2026 | SESE |
| [K252880](/device/K252880.md) | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | May 11, 2026 | SESE |
| [K260011](/device/K260011.md) | Foundation Surgical Navigated Lateral Disc Prep Instruments | Foundation Surgical Group, Inc. | Apr 16, 2026 | SESE |
| [K254158](/device/K254158.md) | SPINEART Navigation Instrument System | Spineart SA | Apr 9, 2026 | SESE |
| [K260240](/device/K260240.md) | SYMPHONY Navigation Ready Instruments | Medos International SARL | Mar 27, 2026 | SESE |

## Top Applicants

- Brainlab AG — 21 clearances
- Mako Surgical Corp. — 19 clearances
- THINK Surgical, Inc. — 19 clearances
- Blue Belt Technologies, Inc. — 18 clearances
- Medtronic Sofamor Danek USA, Inc. — 15 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/OLO](https://fda-staging.innolitics.com/productcode/OLO)

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