510(k) Report

Devices descending from K042037

116 later devices reach M2A Magnum System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131647Trinity Acetabular SystemCorin USA201322—
+1K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+1K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+1K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+1K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+1K062995M2A-Magnum Tri-Spike Acetabular ComponentBiomet Manufacturing Corp200626—
+1K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+1K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH20067413
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+2K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K142761Corin TaperFit Hip StemCorin USA201541
+2K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+2K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+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
+3K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+3K201673SMS Cementless StemMedacta International S.A.20203—
+3K191831MobiliT CupCorin U.S.A. Limited20203—
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K192236Fitmore Hip StemZimmer GmbH20191—
+3K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+3K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+3K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K181693SMS Femoral StemMedacta International S.A.20184—
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+3K170072Fitmore® Hip StemZimmer GmbH20170—
+3K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+3K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+3K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+3K123392Avenir Muller StemZimmer GmbH2013414
+3K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K231925MINIMA S SystemLima Corporate S.P.A.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+4K203041SMS Cementless StemMedacta International S.A.20201—
+4K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+4K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+4K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+4K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+4K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+4K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+4K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+4K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+4K131884Avenir Cemented Hip StemZimmer GmbH20131—
+4K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+4K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+4K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+5K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+5K252451EPORE® XO cup systemImplantcast GmbH20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+5K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+5K233476Z1 Hip SystemOrchard Medical Development202421
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+5K203420EcoFit® Hip SystemImplantcast GmbH20214—
+5K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+5K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+5K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+5K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+5K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+5K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+5K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+5K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+5K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+5K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+6K260831Z1 Hip SystemZimmer, Inc.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K251906Z1 Hip SystemZimmer, Inc.20251—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—