Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osteogenics Biomedical, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
127 daysmedian FDA review time
267 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | 2021-01-23 | 267 | 0 |
| K171774 | RPM Reinforced PTFE Mesh | Osteogenics Biomedical, Inc. | 2017-10-19 | 127 | 0 |
| K093719 | PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# | Osteogenics Biomedical, Inc. | 2010-03-01 | 89 | 0 |
| K072076 | CYTOPLAST PTFE SUTURE | Osteogenics Biomedical, Inc. | 2007-10-31 | 93 | 0 |
| K013764 | IMMIX BONE GRAFT EXTENDER | Osteogenics Biomedical, Inc. | 2002-05-16 | 184 | 0 |
| K003028 | CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-051 | Osteogenics Biomedical, Inc. | 2000-11-24 | 57 | 0 |
| K993610 | CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL | Osteogenics Biomedical, Inc. | 2000-03-02 | 129 | 0 |
| K984230 | OSTEO-MESH TM-300 | Osteogenics Biomedical, Inc. | 1999-02-04 | 71 | 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