Atlas FDA

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

Epic Extremity, LLC — Predicate Candidate Screening

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

87 daysmedian FDA review time
120 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC2019-02-131070
K172441EPIC Extremity Fracture Plate SystemEpic Extremity, LLC2017-11-06870
K163038EPIC Extremity Snap-Off ScrewEpic Extremity, LLC2017-02-281200
K153340Epic Extremity Plate SystemEpic Extremity, LLC2016-02-09820
K153333Epic Extremity Cannulated Screw SystemEpic Extremity, LLC2016-01-19610

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