Class Class II
Icona Hip Stem (K241472)
Description
Icona Hip Stem by Corin U.S.A. Limited, an FDA 510(k) cleared orthopedic device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241472
Clearance Date2024-10-03
Clearance TypeTraditional
Product CodeMEH
Regulation Number888.3353
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241472
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Icona Hip Stem (K241472) cites 7 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212069 | Corin MetaFix Hip Stem | Corin U.S.A. Limited | 2022 |
| K201657 | Corin Ltd. Hip Products: Trinity Acetabular System, Trinit... | Corin, Ltd. | 2021 |
| K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | 2018 |
| K153381 | Corin Metafix Hip Stem | Corin U.S.A. Limited | 2016 |
| K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015 |
| K121439 | METAFIX FEMORAL HIP STEM SIZE 1 | Corin USA | 2012 |
| K082525 | CORIN METAFIX FEMORAL STEM | Corin USA | 2010 |
Trace the full predicate network for K241472
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.