ONN · Intraoperative Orthopedic Joint Assessment Aid
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | ONN |
|---|---|
| Device Name | Intraoperative Orthopedic Joint Assessment Aid |
| 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 (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | Sep 9, 2025 | SESE |
| K241298 | QUADSENSE | Eventum Orthopaedics, Ltd. | Oct 4, 2024 | SESE |
| K242616 | Lantern® Hip | Orthalign, Inc. | Oct 3, 2024 | SESE |
| K220830 | TrueBalance Surgical System | These Three Medical, LLC | Sep 15, 2022 | SESE |
| K200587 | 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 | VERASENSE for Stryker Triathlon | Orthosensor, Inc. | Apr 12, 2020 | SESE |
| K193580 | 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 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | Jun 7, 2018 | SESE |
| K162237 | XO1 Knee Balancing System | Xpandortho, Inc. | Apr 25, 2017 | SESE |
| K150372 | VERASENSE Knee System | Orthosensor, Inc. | Apr 15, 2016 | SESE |
| K132104 | ELIBRA SOFT-TISSUE FORCE SENSOR | Kamm & Associates | Mar 21, 2014 | SESE |
| K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | Orthosensor, Inc. | Nov 8, 2013 | SESE |
| K130380 | ORTHOSENSOR KNEE BALANCER | Orthosensor, Inc. | Jun 13, 2013 | SESE |
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | Synvasive Technology, Inc. | Mar 22, 2011 | SESE |
| K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | Orthosensor, Inc. | Oct 19, 2009 | SESE |
| K070108 | 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
