Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Takiron Co., Ltd. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
218 daysmedian FDA review time
582 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081390 | BIOACTIF OSTEOTRANS INTERFENCE SCREW | Takiron Co., Ltd. | 2008-08-12 | 85 | 0 |
| K073006 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | Takiron Co., Ltd. | 2008-05-29 | 218 | 0 |
| K073312 | OSTEOTRANS-OT SCREW | Takiron Co., Ltd. | 2008-05-13 | 172 | 0 |
| K073311 | OSTEOTRANS-OT PIN | Takiron Co., Ltd. | 2008-05-13 | 172 | 0 |
| K062691 | COMPORUS | Takiron Co., Ltd. | 2008-04-15 | 582 | 0 |
| K061881 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | Takiron Co., Ltd. | 2007-03-14 | 254 | 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