Prosidyan, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Prosidyan, Inc.” (first 2014, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 73 days, against 124 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 |
|---|---|---|
| 2014 | 2 | 108 |
| 2015 | 2 | 148 |
| 2016 | 0 | — |
| 2017 | 2 | 86 |
| 2018 | 2 | 86 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 260 |
| 2023 | 0 | — |
| 2024 | 1 | 51 |
| 2025 | 2 | 26 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Prosidyan, Inc. took a median 73 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 10 | 10 |
| FMF | Syringe, Piston | 2 | 2 |
Review panels
- Orthopedic (10)
- General Hospital (2)
Most recent Prosidyan, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute | MQV | 2025-10-22 | 27 |
| K251648 | GPS Advanced; GPS Advanced Cannula | FMF | 2025-06-24 | 26 |
| K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | FMF | 2024-07-10 | 51 |
| K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft Substitute | MQV | 2022-08-23 | 260 |
| K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute | MQV | 2018-12-20 | 86 |
| K180080 | FIBERGRAFT BG Matrix Bone Graft Substitute | MQV | 2018-04-06 | 86 |
| K171284 | FIBERGRAFT BG Matrix Bone Graft Substitute | MQV | 2017-06-30 | 60 |
| K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | MQV | 2017-05-24 | 113 |
| K151154 | FIBERGRAFT BG Morsels | MQV | 2015-11-10 | 194 |
| K143533 | FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE | MQV | 2015-03-25 | 103 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Prosidyan, 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.
Device clinical trials
An industry sponsor named Prosidyan, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03884283: Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT (Completed, started 2019-02-19)
Frequently asked questions
How many FDA 510(k) clearances are listed under Prosidyan, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Prosidyan, Inc.” (first 2014, latest 2025), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Prosidyan, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prosidyan, Inc. is 86 days. Since 2017: 73 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Prosidyan, Inc.?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 10); FMF (Syringe, Piston, 2).
Next steps
- See all 12 Prosidyan, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MQV, Prosidyan, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.