Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osteobiologics, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
388 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051656 | OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM | Osteobiologics, Inc. | 2005-10-25 | 126 | 0 |
| K041382 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | Osteobiologics, Inc. | 2005-06-17 | 388 | 0 |
| K043172 | TRUGRAFT BGS SYRINGE, MODEL 600-041 | Osteobiologics, Inc. | 2005-01-07 | 52 | 0 |
| K040047 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | Osteobiologics, Inc. | 2004-12-17 | 340 | 1 |
| K033707 | POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS | Osteobiologics, Inc. | 2004-08-16 | 264 | 0 |
| K032673 | IMMIX PLASTIFILM | Osteobiologics, Inc. | 2003-10-02 | 34 | 0 |
| K030288 | POLYGRAFT BONE GRAFT SUBSTITUTE | Osteobiologics, Inc. | 2003-07-17 | 170 | 0 |
| K024199 | IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, P | Osteobiologics, Inc. | 2003-03-14 | 84 | 0 |
| K013429 | ACTAEON PROBE | Osteobiologics, Inc. | 2002-01-11 | 87 | 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