Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ONN · Predicate Candidate Screening
18 FDA 510(k) clearances under this product code; the 50 most recent screened below.
149 daysmedian FDA review time
427 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262253 | Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigat | Orthalign, Inc. | 2026-07-31 | 29 | 0 |
| K253507 | Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Sm | Orthalign, Inc. | 2026-06-02 | 211 | 0 |
| K252524 | Quadsense (Quadsense and Quadsense Pro) | Eventum Orthopaedics, Ltd. | 2025-09-09 | 29 | 0 |
| K241298 | QUADSENSE | Eventum Orthopaedics, Ltd. | 2024-10-04 | 149 | 0 |
| K242616 | Lantern® Hip | Orthalign, Inc. | 2024-10-03 | 30 | 0 |
| K220830 | TrueBalance™ Surgical System | These Three Medical, LLC | 2022-09-15 | 177 | 0 |
| K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Ex | Orthosensor, Inc. | 2020-08-25 | 172 | 0 |
| K200665 | VERASENSE for Stryker Triathlon | Orthosensor, Inc. | 2020-04-12 | 30 | 0 |
| K193580 | VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASEN | Orthosensor, Inc. | 2020-04-01 | 100 | 0 |
| K180459 | VERASENSE for Zimmer Biomet Persona | Orthosensor, Inc. | 2018-06-07 | 107 | 0 |
| K162237 | XO1 Knee Balancing System | Xpandortho, Inc. | 2017-04-25 | 259 | 0 |
| K150372 | VERASENSE Knee System | Orthosensor, Inc. | 2016-04-15 | 427 | 0 |
| K132104 | ELIBRA SOFT-TISSUE FORCE SENSOR | Kamm & Associates | 2014-03-21 | 256 | 0 |
| K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | Orthosensor, Inc. | 2013-11-08 | 144 | 0 |
| K130380 | ORTHOSENSOR KNEE BALANCER | Orthosensor, Inc. | 2013-06-13 | 119 | 1 |
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, | Synvasive Technology, Inc. | 2011-03-22 | 538 | 0 |
| K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | Orthosensor, Inc. | 2009-10-19 | 237 | 0 |
| K070108 | ELIBRA DYNAMIC KNEE BALANCER | Synvasive Technology, Inc. | 2007-04-04 | 83 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda