Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Metagen, LLC — Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
165 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983976METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEMMetagen, LLC1998-12-30510
K980609SEGMENTAL DEFECT REPLACEMENT SYSTEMMetagen, LLC1998-05-18900
K980020ACTIVELOCK MODULAR FEMORAL HIP SYSTEMMetagen, LLC1998-04-03880
K964003METAGEN ALL POLY ACETABULAR CUP SYSTEMMetagen, LLC1997-03-211650
K963700METAGEN HIGH TIBIAL OSTEOTOMY SYSTEMMetagen, LLC1997-02-121490

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