510(k) Report

Devices descending from K934412

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K170690M-Vizion Femoral Revision SystemMedacta International S.A.20175—
+4K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+4K161226Revision Femoral StemLima Corporate S.P.A.20170—
+4K170072Fitmore® Hip StemZimmer GmbH20170—
+4K161610EXPRT Revision Hip SystemEncore Medical L.P.20161—
+4K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+4K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+4K123392Avenir Muller StemZimmer GmbH2013414
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K112158Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.201213—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K110836CLS Brevius Stem with Kinectiv TechnologyZimmer GmbH201101
+4K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp201134—
+4K111145Endo HeadMedacta International20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K110947Apex K1 Hip StemOmni Life Science, Inc.20116—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc.20083—
+4K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Zimmer, Inc.20073Class I
+4K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051681
+4K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.200423—
+4K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048—
+4K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+5K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+5K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K251166Mfinity Femoral SystemMedacta International S.A.20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—
+5K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K243809Biolox® Delta Revision headsLimacorporate20250—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K212327M-Vizion MonoblocMedacta International S.A.20221—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K211703Insignia Hip StemStryker Orthopaedics20217—
+5K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+5K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+5K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+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—
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+5K183312Conformity StemUnited Orthopedic Corporation20193—
+5K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+5K191374Revival Modular Hip StemCorin U.S.A. Limited20193—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+5K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+5K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+5K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+5K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+5K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+5K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20160—
+5K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+5K152903REVIVAL (TM) Modular Revision Hip StemCorin USA20164—
+5K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+5K143009Echo Bi-Metric Microplasty Hip SystemBiomet, Inc.20141—
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K133386Ovation Tribute Hip Stem; Ovation Narrow Hip StemOrtho Development Corp.20143—