Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthosensor, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
144 daysmedian FDA review time
427 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| 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 |
| K150372 | VERASENSE Knee System | Orthosensor, Inc. | 2016-04-15 | 427 | 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 |
| K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | Orthosensor, Inc. | 2009-10-19 | 237 | 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