510(k) Report

Devices descending from K934412

377 later devices reach Coated ZT Proximal Sleeve through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K052426Smith & Nephew Modular HipSmith & Nephew, Inc.20056—
+1K042127Smith & Nephew Modular HipSmith & Nephew, Inc.200417—
+1K000788Apex Modular Hip StemApex Surgical, LLC2000168—
+1K994286ZMR Hip System-Porous RevisionZimmer, Inc.200010511
+1K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996210—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K241472Icona Hip StemCorin U.S.A. Limited20241—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K113296ZMR Hip System KWZ-Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/PolymerZimmer, Inc.20122—
+2K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+2K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+2K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+2K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+2K070554Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc.200749—
+2K061221Dupuy S-Rom STD Hip Stem ProsthesisDePuy Orthopaedics, Inc.20060—
+2K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+2K043123Apex Modular HA Hip StemApex Surgical, LLC2005131—
+2K041950Apex K2 Hip SystemApex Surgical, LLC2004621
+2K041850Medallion Modular Hip SystemBiomet Manufacturing, Inc.20041—
+2K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+2K032726Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc.2003843
+2K031572ZMR Hip System-XL, Models 9921, 9922 and 9923Zimmer, Inc.2003286
+2K992403MRP-TitanRotec Medizintechnik GmbH20000—
+2K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998189—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K261576Icona Hip StemCorin, Ltd.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+3K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K192660Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20202—
+3K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+3K163577Ecofit® Hip SystemImplantcast GmbH201791
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+3K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc.20160—
+3K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+3K151739Revision Femoral StemLima Corporate S.P.A.20157—
+3K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+3K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+3K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+3K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K092331Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200; 428-00-050/110;Encore Medical L.P.2010271
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+3K071723Zimmer Porolock Mis StemZimmer GmbH2008732
+3K063251Zimmer M/L Taper Hip Prosthesis with Modular Neck TechnologyZimmer, Inc.200754
+3K060072Monoblock Press-Fit Hip StemOmni Life Science, Inc.200671
+3K060040Zimmer M/L Taper Hip ProsthesisZimmer, Inc.200632
+3K042337Zimmer M/L Taper Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.200411—
+3K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000188—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K252451EPORE® XO cup systemImplantcast GmbH20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+4K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+4K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+4K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+4K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K203420EcoFit® Hip SystemImplantcast GmbH20214—
+4K201673SMS Cementless StemMedacta International S.A.20203—
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K191816M-Vizion Femoral Revision System ExtensionMedacta International S.A.20204—
+4K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+4K192236Fitmore Hip StemZimmer GmbH20191—
+4K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+4K182678Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR LabelingZimmer, Inc.20191—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K181693SMS Femoral StemMedacta International S.A.20184—
+4K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—