Atlas FDA

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

Corin U.S.A. Limited — Predicate Candidate Screening

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

132 daysmedian FDA review time
279 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited2025-06-052670
K241808ApolloHipX (THR.SS.0001)Corin U.S.A. Limited2025-01-072000
K241472Icona Hip StemCorin U.S.A. Limited2024-10-031320
K241570Unity Total Knee SystemCorin U.S.A. Limited2024-09-231150
K240875Unity Knee PS-C Tibial InsertCorin U.S.A. Limited2024-06-26890
K231172ApolloKneeCorin U.S.A. Limited2023-07-26920
K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited2022-04-072790
K191831MobiliT CupCorin U.S.A. Limited2020-01-161910
K191374Revival Modular Hip StemCorin U.S.A. Limited2019-07-22600
K183114Corin BiPolar-iCorin U.S.A. Limited2019-06-052080
K183533Unity Total Knee SystemCorin U.S.A. Limited2019-06-041670
K172551Trinity PLUS Acetabular ShellCorin U.S.A. Limited2018-06-152960
K173880Corin TriFit CF Hip StemCorin U.S.A. Limited2018-04-111110
K171847Corin Optimized Positioning System (OPS™) PlanCorin U.S.A. Limited2018-04-052880
K173884Unity Total Knee SystemCorin U.S.A. Limited2018-01-17270
K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017-10-312670
K170808Unity Total Knee SystemCorin U.S.A. Limited2017-07-131180
K162942Corin MetaFix Hip StemCorin U.S.A. Limited2017-06-202420
K153772Corin TriFit TS HipCorin U.S.A. Limited2016-03-31910
K153725Corin TaperFit Hip StemCorin U.S.A. Limited2016-03-25880
K153381Corin Metafix Hip StemCorin U.S.A. Limited2016-01-21590

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