Orthonovis, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Orthonovis, Inc.” (first 2022, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 34 days. Since 2017 the median was 34 days, against 97 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 254 |
| 2023 | 0 | — |
| 2024 | 1 | 58 |
| 2025 | 3 | 27 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthonovis, Inc. took a median 34 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 97 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Orthonovis, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252758 | Cannulated Screw and Kirschner (K wire) System | HWC | 2025-10-02 | 34 |
| K250498 | BPS Wrist Fracture System | HRS | 2025-03-17 | 25 |
| K250055 | BPS - Bone Fragment Fixation Plates, Screws and Washers | HRS | 2025-02-06 | 27 |
| K242343 | BPS Wrist Fracture System | HRS | 2024-10-04 | 58 |
| K213905 | ONX Large External Fixation System | KTT | 2022-08-25 | 254 |
Recalls
openFDA lists no recalls under a recalling firm named Orthonovis, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthonovis, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Orthonovis, Inc.” (first 2022, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Orthonovis, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthonovis, Inc. is 34 days. Since 2017: 34 days, versus 97 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthonovis, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 3); HWC (Screw, Fixation, Bone, 1); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 1).
Next steps
- See all 5 Orthonovis, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Orthonovis, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.