510(k) Report

Devices descending from K960538

121 later devices reach Opteon Unipolar through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K010081Acumatch L-Series Unipolar EndoprosthesisExactech, Inc.20012—
+1K984028The New Bio-Moore Endo HeadsBiomet, Inc.1999117—
+2K042037M2A Magnum SystemBiomet, Inc.2004116—
+2K021109Esop CO-CR Femoral HeadsFournitures Hospitalieres20021—
+3K131647Trinity Acetabular SystemCorin USA201322—
+3K113271Metal-on-Metal Hip Systems-Additional ContraindicationsBiomet Manufacturing, Inc.20120—
+3K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+3K082446Biomet Metal-on-Metal Hip Systems- Expanded ContraindicationsBiomet, Inc.200821
+3K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+3K062995M2A-Magnum Tri-Spike Acetabular ComponentBiomet Manufacturing Corp200626—
+3K061423M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsBiomet Manufacturing Corp20063—
+3K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH20067413
+3K050556Alumina HeadFournitures Hospitalieres Industrie20050—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+4K152893Corin Optimized Positioning System (OPS)Corin USA20168—
+4K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+4K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+4K142761Corin TaperFit Hip StemCorin USA201541
+4K083642Depuy Pinnacle Metal-on-Metal Acetabular Cup LinersDePuy Orthopaedics, Inc.20090—
+4K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+5K202373APEX 3D Total Ankle Replacement SystemParagon 28, Inc.20200—
+5K201673SMS Cementless StemMedacta International S.A.20203—
+5K191831MobiliT CupCorin U.S.A. Limited20203—
+5K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+5K192236Fitmore Hip StemZimmer GmbH20191—
+5K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+5K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA)Corin USA20195—
+5K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+5K181693SMS Femoral StemMedacta International S.A.20184—
+5K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K170072Fitmore® Hip StemZimmer GmbH20170—
+5K153725Corin TaperFit Hip StemCorin U.S.A. Limited20163—
+5K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+5K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+5K123392Avenir Muller StemZimmer GmbH2013414
+5K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K211567BiMobile Instruments (for BiMobile Dual Mobility System)Waldemar Link GmbH & Co. KG20220—
+6K203041SMS Cementless StemMedacta International S.A.20201—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+6K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+6K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+6K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+6K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+6K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+6K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+6K163577Ecofit® Hip SystemImplantcast GmbH201791
+6K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+6K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+6K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+6K141327Minima S SystemLima Corporate S.P.A.20145—
+6K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+6K131884Avenir Cemented Hip StemZimmer GmbH20131—
+6K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+6K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+6K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+7K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+7K252451EPORE® XO cup systemImplantcast GmbH20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+7K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+7K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+7K233476Z1 Hip SystemOrchard Medical Development202421
+7K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+7K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+7K210678implaFit® hip stemsImplantcast GmbH20223—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K203420EcoFit® Hip SystemImplantcast GmbH20214—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+7K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+7K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+7K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+7K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+7K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+7K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+7K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+7K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+7K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—