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MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Class II

FDA Device Classification

Classification Details

Product Code
MEH
Device Class
Class II
Regulation Number
888.3353
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250375waldemar link gmbh and co. kgAllure Hip Stem and Intramedullary PlugsNovember 5, 2025
K251166medacta internationalMfinity Femoral SystemJune 13, 2025
K251052ortho developmentTrivicta® Hip StemMay 22, 2025
K242315united orthopedic corporationResolve Modular Revision Hip StemMay 1, 2025
K243839exactechAlteon® HA Femoral StemsMarch 10, 2025
K243162signature orthopaedics ptyWorld LinerNovember 25, 2024
K241472corin u.s.a. limitedIcona Hip StemOctober 3, 2024
K241875nextstep arthropedixTheRay Collared and Collarless Femoral StemSeptember 13, 2024
K241690signature orthopaedics ptyLogical Liner; World Liner; World Knee PatellaAugust 1, 2024
K233758ortho developmentTrivicta™ Hip StemMarch 8, 2024
K231873depuy ireland ucDePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip PJanuary 19, 2024
K231178conformisACTERA™ hip systemMay 23, 2023
K220495signature orthopaedics ptySignaSure Dual Mobility SystemJanuary 13, 2023
K220731strykerInsignia Hip Stem, Restoration Modular 115mm Conical Distal StemAugust 11, 2022
K221104conformisActera™ hip systemAugust 4, 2022
K211742signature orthopaedics ptySignaSure Dual Mobility SystemJanuary 7, 2022
K211505signature orthopaedics ptyEncore Hip StemSeptember 24, 2021
K211703stryker orthopaedicsInsignia Hip StemAugust 16, 2021
K210581depuy ireland ucActis DuoFix Hip Prosthesis- CollarlessMay 20, 2021
K200045implantcastMUTARS Cemented Femoral StemsOctober 16, 2020