Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Prosidyan, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
194 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253147 | FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ B | Prosidyan, Inc. | 2025-10-22 | 27 | 0 |
| K251648 | GPS Advanced; GPS Advanced Cannula | Prosidyan, Inc. | 2025-06-24 | 26 | 0 |
| K241426 | GPS Advanced; 5 cc GPS Advanced Cannula | Prosidyan, Inc. | 2024-07-10 | 51 | 0 |
| K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft Substitute | Prosidyan, Inc. | 2022-08-23 | 260 | 0 |
| K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute | Prosidyan, Inc. | 2018-12-20 | 86 | 0 |
| K180080 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | 2018-04-06 | 86 | 0 |
| K171284 | FIBERGRAFT BG Matrix Bone Graft Substitute | Prosidyan, Inc. | 2017-06-30 | 60 | 0 |
| K170306 | FIBERGRAFT BG Putty Bone Graft Substitute | Prosidyan, Inc. | 2017-05-24 | 113 | 0 |
| K151154 | FIBERGRAFT BG Morsels | Prosidyan, Inc. | 2015-11-10 | 194 | 0 |
| K143533 | FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTE | Prosidyan, Inc. | 2015-03-25 | 103 | 0 |
| K141956 | FIBERGRAFT BG MORSELS | Prosidyan, Inc. | 2014-08-13 | 26 | 0 |
| K132805 | BG MORSELS | Prosidyan, Inc. | 2014-03-14 | 189 | 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