Conventus Orthopaedics, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Conventus Orthopaedics, Inc.” (first 2013, latest 2021), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 187 days. 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 |
|---|---|---|
| 2013 | 1 | 853 |
| 2014 | 1 | 258 |
| 2015 | 2 | 184 |
| 2016 | 1 | 103 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 116 |
| 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 Conventus Orthopaedics, Inc. took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 4 | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| JDS | Nail, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Conventus Orthopaedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | HSB | 2021-01-22 | 116 |
| K161048 | Conventus Orthopaedics Ulna Fixation System | HRS | 2016-07-26 | 103 |
| K151379 | Conventus PRS System | HRS | 2015-08-13 | 83 |
| K141737 | CONVENTUS PHS SYSTEM | JDS | 2015-04-08 | 285 |
| K131552 | CONVENTUS DRS | HRS | 2014-02-12 | 258 |
| K102689 | CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM | HRS | 2013-01-17 | 853 |
Recalls
openFDA lists no recalls under a recalling firm named Conventus Orthopaedics, 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 Conventus Orthopaedics, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Conventus Orthopaedics, Inc.” (first 2013, latest 2021), 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 Conventus Orthopaedics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Conventus Orthopaedics, Inc. is 187 days.
Which FDA product codes appear under Conventus Orthopaedics, Inc.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 4); HSB (Rod, Fixation, Intramedullary And Accessories, 1); JDS (Nail, Fixation, Bone, 1).
Next steps
- See all 6 Conventus Orthopaedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Conventus Orthopaedics, 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.