Intraoperative Orthopedic Joint Assessment Aid
The Intraoperative Orthopedic Joint Assessment Aid (product code ONN) is a Class 2 device regulated under 21 CFR 882.4560, reviewed by the Orthopedic panel in the Neurology specialty classification (NE), cleared via 510(k). It is intended for the intraoperative measurement and interpretation of orthopedic joint information to assist surgeons during joint procedures. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- ONN
- Device Class
- FDA class 2
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
Measurement and interpretation of orthopedic joint information.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | Jun 02, 2026 | Substantially Equivalent | Orthalign, Inc. |
| K252524 | Quadsense (Quadsense and Quadsense Pro) | Sep 09, 2025 | Substantially Equivalent | Eventum Orthopaedics, Ltd. |
| K241298 | QUADSENSE | Oct 04, 2024 | Substantially Equivalent | Eventum Orthopaedics, Ltd. |
| K242616 | Lantern® Hip | Oct 03, 2024 | Substantially Equivalent | Orthalign, Inc. |
| K220830 | TrueBalance Surgical System | Sep 15, 2022 | Substantially Equivalent | These Three Medical, LLC |
| 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 | Aug 25, 2020 | Substantially Equivalent | Orthosensor, Inc. |
| K200665 | VERASENSE for Stryker Triathlon | Apr 12, 2020 | Substantially Equivalent | Orthosensor, Inc. |
| 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 | Apr 01, 2020 | Substantially Equivalent | Orthosensor, Inc. |
| K180459 | VERASENSE for Zimmer Biomet Persona | Jun 07, 2018 | Substantially Equivalent | Orthosensor, Inc. |
| K162237 | XO1 Knee Balancing System | Apr 25, 2017 | Substantially Equivalent | Xpandortho, Inc. |
| K150372 | VERASENSE Knee System | Apr 15, 2016 | Substantially Equivalent | Orthosensor, Inc. |
| K132104 | ELIBRA SOFT-TISSUE FORCE SENSOR | Mar 21, 2014 | Substantially Equivalent | Kamm & Associates |
| K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | Nov 08, 2013 | Substantially Equivalent | Orthosensor, Inc. |
| K130380 | ORTHOSENSOR KNEE BALANCER | Jun 13, 2013 | Substantially Equivalent | Orthosensor, Inc. |
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | Mar 22, 2011 | Substantially Equivalent | Synvasive Technology, Inc. |
| K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | Oct 19, 2009 | Substantially Equivalent | Orthosensor, Inc. |
| K070108 | ELIBRA DYNAMIC KNEE BALANCER | Apr 04, 2007 | Substantially Equivalent | Synvasive Technology, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.