Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthonovis, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
254 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252758 | Cannulated Screw and Kirschner (K wire) System | Orthonovis, Inc. | 2025-10-02 | 34 | 0 |
| K250498 | BPS Wrist Fracture System | Orthonovis, Inc. | 2025-03-17 | 25 | 0 |
| K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | Orthonovis, Inc. | 2025-02-06 | 27 | 0 |
| K242343 | BPS Wrist Fracture System | Orthonovis, Inc. | 2024-10-04 | 58 | 0 |
| K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022-08-25 | 254 | 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