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) → ONN — Intraoperative Orthopedic Joint Assessment Aid

# ONN · Intraoperative Orthopedic Joint Assessment Aid

_Neurology · 21 CFR 882.4560 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN

## Overview

- **Product Code:** ONN
- **Device Name:** Intraoperative Orthopedic Joint Assessment Aid
- **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 (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252524](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K252524.md) | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | Sep 9, 2025 | SESE |
| [K241298](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K241298.md) | QUADSENSE | Eventum Orthopaedics, Ltd. | Oct 4, 2024 | SESE |
| [K242616](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K242616.md) | Lantern® Hip | Orthalign, Inc. | Oct 3, 2024 | SESE |
| [K220830](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K220830.md) | TrueBalance™ Surgical System | These Three Medical, LLC | Sep 15, 2022 | SESE |
| [K200587](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K200587.md) | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder | Orthosensor, Inc. | Aug 25, 2020 | SESE |
| [K200665](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K200665.md) | VERASENSE for Stryker Triathlon | Orthosensor, Inc. | Apr 12, 2020 | SESE |
| [K193580](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K193580.md) | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left | Orthosensor, Inc. | Apr 1, 2020 | SESE |
| [K180459](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K180459.md) | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | Jun 7, 2018 | SESE |
| [K162237](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K162237.md) | XO1 Knee Balancing System | Xpandortho, Inc. | Apr 25, 2017 | SESE |
| [K150372](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K150372.md) | VERASENSE Knee System | Orthosensor, Inc. | Apr 15, 2016 | SESE |
| [K132104](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K132104.md) | ELIBRA SOFT-TISSUE FORCE SENSOR | Kamm & Associates | Mar 21, 2014 | SESE |
| [K131767](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K131767.md) | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | Orthosensor, Inc. | Nov 8, 2013 | SESE |
| [K130380](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K130380.md) | ORTHOSENSOR KNEE BALANCER | Orthosensor, Inc. | Jun 13, 2013 | SESE |
| [K093046](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K093046.md) | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | Synvasive Technology, Inc. | Mar 22, 2011 | SESE |
| [K090474](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K090474.md) | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | Orthosensor, Inc. | Oct 19, 2009 | SESE |
| [K070108](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN/K070108.md) | ELIBRA DYNAMIC KNEE BALANCER | Synvasive Technology, Inc. | Apr 4, 2007 | SESE |

## Top Applicants

- Orthosensor, Inc. — 8 clearances
- Eventum Orthopaedics, Ltd. — 2 clearances
- Synvasive Technology, Inc. — 2 clearances
- Kamm & Associates — 1 clearance
- Orthalign, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/ONN)

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