Orthosensor, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Orthosensor, Inc.” (first 2009, latest 2020), across 1 product code in 1 review panel. Median 510(k) review time under this name: 132 days. Since 2017 the median was 104 days, against 107 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 132 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 427 |
| 2017 | 0 | — |
| 2018 | 1 | 107 |
| 2019 | 0 | — |
| 2020 | 3 | 100 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Orthosensor, Inc. took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ONN | Intraoperative Orthopedic Joint Assessment Aid | 8 | 8 |
Review panels
- Orthopedic (8)
Most recent Orthosensor, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200587 | VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder | ONN | 2020-08-25 | 172 |
| K200665 | VERASENSE for Stryker Triathlon | ONN | 2020-04-12 | 30 |
| 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 Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left | ONN | 2020-04-01 | 100 |
| K180459 | VERASENSE for Zimmer Biomet Persona | ONN | 2018-06-07 | 107 |
| K150372 | VERASENSE Knee System | ONN | 2016-04-15 | 427 |
| K131767 | ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM | ONN | 2013-11-08 | 144 |
| K130380 | ORTHOSENSOR KNEE BALANCER | ONN | 2013-06-13 | 119 |
| K090474 | ORTHOREX INTRA-OPERATIVE LOAD SENSOR | ONN | 2009-10-19 | 237 |
Recalls
8 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2018-07-12.
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.
Device clinical trials
An industry sponsor named Orthosensor, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05091918: Limited Market Release - MotionSense Clinical Use Evaluation (Completed, started 2021-05-27)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orthosensor, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Orthosensor, Inc.” (first 2009, latest 2020), across 1 product code 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 Orthosensor, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orthosensor, Inc. is 132 days. Since 2017: 104 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Orthosensor, Inc.?
The most frequent FDA product codes under this applicant name are ONN (Intraoperative Orthopedic Joint Assessment Aid, 8).
Next steps
- See all 8 Orthosensor, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ONN, Orthosensor, 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.