510(k) Report

Devices descending from K050441

85 later devices reach Taper 2 Porous Femoral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062994Lateralized Taperloc Microplasty Femoral ComponentsBiomet Manufacturing Corp200784—
+2K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+2K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+2K121563Corin Trifit TS HipCorin USA2012101
+2K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+2K072417Smith & Nephew Mis Hip StemSmith & Nephew, Inc.2008441
+3K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+3K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K173880Corin TriFit CF Hip StemCorin U.S.A. Limited20183—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K153772Corin TriFit TS HipCorin U.S.A. Limited20164—
+3K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+3K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+3K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—
+3K123619Intrablock Bioball Hip System (Ibs)Merete Medical GmbH20131—
+3K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+3K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp201214—
+3K083312Minihip StemCorin USA201015—
+3K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+3K080625Smith & Nephew Mis Hip Stem with StiktiteSmith & Nephew, Inc.2008191
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+4K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+4K210263Mpres Neck Preserving StemMedacta International S.A.20211—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+4K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+4K162775Legion Cone SystemSmith & Nephew, Inc.201752
+4K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K150503Echo Bi-Metric Microplasty Line ExtensionBiomet, Inc.20150—
+4K141377Bioball Delta Ceramic Heads, Multicup PE Inlay StandardMerete Medical GmbH20140—
+4K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+4K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+4K131986Corin Minihip StemCorin USA20133—
+4K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+4K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+4K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+4K103518Trinity Acetabular SystemCorin USA20118—
+4K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc.2011162
+4K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K250450Coated hip implantsMedacta International S.A.20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+5K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+5K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K123012Smith & Nephew SMF Hip StemSmith & Nephew, Inc.201210—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+6K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+6K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+6K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+6K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+7K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—