510(k) Report

Devices descending from K052026

125 later devices reach Lineage a-Class Poly Liner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K221636EMPHASYS Acetabular SystemDepuy Ireland UC20227—
+5K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+5K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K143453Mpact Double Mobility SystemMedacta International20151—
+5K132879Mpact ExtensionMedacta International201411—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131458Mpact DM Liner ConverterMedacta International20133—
+5K122911Versafitcup CC Trio ExtensionMedacta International20121—
+5K122641Mpact ExtensionMedacta International201214—
+5K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+5K111145Endo HeadMedacta International20110—
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+6K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K211891DM Converter - TiN coatedMedacta International S.A.20220—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K232371Actinia® hip stemsImplantcast GmbH20231—