510(k) Report

Devices descending from K980513

109 later devices reach Articul/Eze Femoral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+1K222296ARTICUL/EZE Ceramic HeadsDepuy Ireland UC20236—
+1K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+1K141327Minima S SystemLima Corporate S.P.A.20145—
+1K120599Depuy M-Spec 36MM Femoral HeadsDepuy Orthopaedics20136—
+1K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+1K082585Depuy Asphere M-Spec HeadDePuy Orthopaedics, Inc.20087—
+1K060031Depuy Modular M HeadsDePuy Orthopaedics, Inc.200618—
+1K033634Epsilon Metasul 32MM Acetabular Inserts, Standard and HoodedCenterpulse Orthopedics, Inc.2004762
+2K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K243809Biolox® Delta Revision headsLimacorporate20250—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K231925MINIMA S SystemLima Corporate S.P.A.20230—
+2K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+2K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+2K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+2K091973Metasul Taper Liners, Metasul Femoral HeadsZimmer GmbH200904
+2K071117Modification to Pinnacle Constrained Acetabular LinersDePuy Orthopaedics, Inc.200761
+2K053536Durom Acetabular Component and Metasul LDH Large Diameter HeadsZimmer GmbH20067413
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC20240—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner…Signature Orthopaedics Pty, Ltd.20164—
+3K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K201673SMS Cementless StemMedacta International S.A.20203—
+4K192236Fitmore Hip StemZimmer GmbH20191—
+4K181693SMS Femoral StemMedacta International S.A.20184—
+4K170072Fitmore® Hip StemZimmer GmbH20170—
+4K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+4K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+4K123392Avenir Muller StemZimmer GmbH2013414
+4K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+5K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+5K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+5K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+5K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+5K163577Ecofit® Hip SystemImplantcast GmbH201791
+5K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+5K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+5K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+5K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+5K131884Avenir Cemented Hip StemZimmer GmbH20131—
+5K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+5K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+5K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+6K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K241241Z1 Cemented Hip SystemOrchard Medical Development, LLC20240—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K233476Z1 Hip SystemOrchard Medical Development202421
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K223828BENCOX Delta Option HeadsCorentec Co., Ltd.20230—
+6K210678implaFit® hip stemsImplantcast GmbH20223—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+6K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+6K182462Exactech Alteon Highly Polished Femoral StemExactech, Inc.20180—
+6K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+6K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+6K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+6K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+6K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+6K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+7K260831Z1 Hip SystemZimmer, Inc.20260—
+7K252401implaFit® short stemsImplantcast GmbH20260—
+7K251906Z1 Hip SystemZimmer, Inc.20251—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K232371Actinia® hip stemsImplantcast GmbH20231—
+7K192126AMIStem-P Short NeckMedacta International S.A.20191—
+7K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—