Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioretec, Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
329 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| DEN220030 | RemeOs™ Screw LAG Solid | Bioretec, Ltd. | 2023-03-29 | 329 | 0 |
| K133950 | ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) | Bioretec, Ltd. | 2014-01-22 | 30 | 0 |
| K130716 | BIORETEC ACTIVASCREW INTERFERENCE | Bioretec, Ltd. | 2013-08-28 | 166 | 0 |
| K080879 | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIV | Bioretec, Ltd. | 2008-06-24 | 85 | 0 |
| K081392 | BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW | Bioretec, Ltd. | 2008-06-18 | 30 | 0 |
| K072848 | ACTIVASCREW | Bioretec, Ltd. | 2007-11-02 | 29 | 0 |
| K071863 | ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM | Bioretec, Ltd. | 2007-08-31 | 56 | 0 |
| K062980 | ACTIVASCREW | Bioretec, Ltd. | 2006-11-22 | 54 | 0 |
| K061164 | ACTIVAPIN | Bioretec, Ltd. | 2006-07-06 | 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