Intraoperative Orthopedic Joint Assessment Aid
Regulation 882.4560
2510(k)s in 12 months (18 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in ONN
| Company | 510(k)s | Recalls |
|---|---|---|
| Orthosensor, Inc. | 8 | 8 |
| Orthalign, Inc. | 3 | 0 |
| Eventum Orthopaedics, Ltd. | 2 | 0 |
| Synvasive Technology, Inc. | 2 | 0 |
| Kamm & Associates | 1 | 0 |
| These Three Medical, LLC | 1 | 0 |
| Xpandortho, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2026 | K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) Orthalign, Inc. | ONN |
| Jun 2, 2026 | K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee Orthalign, Inc. | ONN |
| Sep 9, 2025 | K252524 | Quadsense (Quadsense and Quadsense Pro) Eventum Orthopaedics, Ltd., GB | ONN |
| Oct 4, 2024 | K241298 | QUADSENSE Eventum Orthopaedics, Ltd., GB | ONN |
| Oct 3, 2024 | K242616 | Lantern® Hip Orthalign, Inc. | ONN |
| Sep 15, 2022 | K220830 | TrueBalance Surgical System These Three Medical, LLC | ONN |
| Aug 25, 2020 | K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MI Orthosensor, Inc. | ONN |
| Apr 12, 2020 | K200665 | VERASENSE for Stryker Triathlon Orthosensor, Inc. | ONN |
| Apr 1, 2020 | 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 Orthosensor, Inc. | ONN |
| Jun 7, 2018 | K180459 | VERASENSE for Zimmer Biomet Persona Orthosensor, Inc. | ONN |
| Apr 25, 2017 | K162237 | XO1 Knee Balancing System Xpandortho, Inc. | ONN |
| Apr 15, 2016 | K150372 | VERASENSE Knee System Orthosensor, Inc. | ONN |
| Mar 21, 2014 | K132104 | ELIBRA SOFT-TISSUE FORCE SENSOR Kamm & Associates | ONN |
| Nov 8, 2013 | K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM Orthosensor, Inc. | ONN |
| Jun 13, 2013 | K130380 | ORTHOSENSOR KNEE BALANCER Orthosensor, Inc. | ONN |
| Mar 22, 2011 | K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES Synvasive Technology, Inc. | ONN |
| Oct 19, 2009 | K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR Orthosensor, Inc. | ONN |
| Apr 4, 2007 | K070108 | ELIBRA DYNAMIC KNEE BALANCER Synvasive Technology, Inc. | ONN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.