ONN — Intraoperative Orthopedic Joint Assessment Aid Class II
FDA product code ONN covers "Intraoperative Orthopedic Joint Assessment Aid", a Class II medical device regulated under 21 CFR 882.4560. Submissions are reviewed by the Neurology panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ONN
- Device Class
- Class II
- Regulation Number
- 882.4560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Neurology
- Implant
- No
Definition
Measurement and interpretation of orthopedic joint information.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262253 | orthalign | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) | July 31, 2026 |
| K253507 | orthalign | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee | June 2, 2026 |
| K252524 | eventum orthopaedics | Quadsense (Quadsense and Quadsense Pro) | September 9, 2025 |
| K241298 | eventum orthopaedics | QUADSENSE | October 4, 2024 |
| K242616 | orthalign | Lantern® Hip | October 3, 2024 |
| K220830 | these three medical | TrueBalance Surgical System | September 15, 2022 |
| K200587 | orthosensor | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size | August 25, 2020 |
| K200665 | orthosensor | VERASENSE for Stryker Triathlon | April 12, 2020 |
| K193580 | orthosensor | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet | April 1, 2020 |
| K180459 | orthosensor | VERASENSE for Zimmer Biomet Persona | June 7, 2018 |
| K162237 | xpandortho | XO1 Knee Balancing System | April 25, 2017 |
| K150372 | orthosensor | VERASENSE Knee System | April 15, 2016 |
| K132104 | kamm and associates | ELIBRA SOFT-TISSUE FORCE SENSOR | March 21, 2014 |
| K131767 | orthosensor | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | November 8, 2013 |
| K130380 | orthosensor | ORTHOSENSOR KNEE BALANCER | June 13, 2013 |
| K093046 | synvasive technology | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | March 22, 2011 |
| K090474 | orthosensor | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | October 19, 2009 |
| K070108 | synvasive technology | ELIBRA DYNAMIC KNEE BALANCER | April 4, 2007 |