510(k) Report

Devices descending from K083116

59 later devices reach Versafit Cup Double Mobility System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143453Mpact Double Mobility SystemMedacta International20151—
+1K131458Mpact DM Liner ConverterMedacta International20133—
+1K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+1K110135Polarcup Dual Mobility SystemSmith & Nephew, Inc.201114—
+1K103721Mpact Acetabular SystemMedacta International201121—
+1K103352Versafitcup CC TrioMedacta International20114—
+1K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+1K092265Vesafitcup Double Mobility- Highcross Hxuhmwpe LinersMedacta International S.A.201023—
+2K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+2K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+2K250450Coated hip implantsMedacta International S.A.20250—
+2K241461Mpact Constrained LinerMedacta International S.A.20251—
+2K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+2K230011Mpact ExtensionMedacta International S.A.20233—
+2K220959OR3O Dual Mobility SystemSmith & Nephew, Inc.20223—
+2K211891DM Converter - TiN coatedMedacta International S.A.20220—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+2K200391MPACT ExtensionMedacta International S.A.20210—
+2K191002OR3O Dual Mobility SystemSmith & Nephew, Inc.20195—
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K183582MPACT ExtensionMedacta International S.A.20194—
+2K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+2K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+2K171934Birmingham Hip (BH) Dual Mobility InsertSmith & Nephew, Inc.20179—
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K132879Mpact ExtensionMedacta International201411—
+2K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+2K122911Versafitcup CC Trio ExtensionMedacta International20121—
+2K122641Mpact ExtensionMedacta International201214—
+2K122244Polarcup Dual Mobility SystemSmith & Nephew, Inc.20125—
+2K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+2K111145Endo HeadMedacta International20110—
+2K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+3K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K232667OR3O Dual Mobility LinersSmith & Nephew, Inc.20231—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K261576Icona Hip StemCorin, Ltd.20260—