510(k) Report

Devices descending from K031110

217 later devices reach Apex Modular Acetabular Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K243927MobileLink Acetabular Cup System - inhouse coatingsWaldemar Link GmbH & Co. KG20250—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+4K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+4K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K192198Conformis Hip SystemConformis, Inc.2019121
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+4K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+4K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+4K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K121636Zenith, Femoral Stem Zenith, Distal Centralizer Fomoral Head Acetabular InsertTgm Medical, Inc.20121—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K111145Endo HeadMedacta International20110—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231178ACTERA™ hip systemConformis, Inc.20230—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+5K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+5K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+5K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K130634Corin Metafix Hip StemCorin USA20135—
+5K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K223223BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20230—
+6K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+6K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+7K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+7K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+7K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+7K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301
+7K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—