510(k) Report

Devices descending from K921274

644 later devices reach Metallic Toatal Hip System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K181693SMS Femoral StemMedacta International S.A.20184—
+4K180263EcoFit Vit E Acetabular SystemImplantcast GmbH20185—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal…Encore Medical L.P.201701
+4K170072Fitmore® Hip StemZimmer GmbH20170—
+4K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+4K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+4K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+4K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+4K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K140547Excera Fitrite Total Hip Arthroplasty SystemExcera Orthopedics, Inc.20151—
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+4K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+4K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+4K132879Mpact ExtensionMedacta International201411—
+4K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+4K130899Biolox Delta Ceramic Femoral HeadsZimmer GmbH201319—
+4K123392Avenir Muller StemZimmer GmbH2013414
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc.20120—
+4K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+4K122641Mpact ExtensionMedacta International201214—
+4K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+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—
+4K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+4K111145Endo HeadMedacta International20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K110947Apex K1 Hip StemOmni Life Science, Inc.20116—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+4K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K090103100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallBiomet, Inc.2009153—
+4K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+4K081007Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology SystemZimmer, Inc.20083—
+4K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+4K071856Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology System, Model (S) 7848 Series (…Zimmer, Inc.20073Class I
+4K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006343—
+4K042774Mallory-Head Modular Calcar Stems with Interlocking SlotsBiomet, Inc.200538—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K251270Taperloc® Complete Hip StemBiomet, Inc.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+5K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+5K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+5K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231925MINIMA S SystemLima Corporate S.P.A.20230—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+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
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K200112Zimmer Hip Joint ReplacementZimmer GmbH202002
+5K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+5K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K183684Libertas – Taper Uncemented Femoral StemMaxx Orthopedics, Inc.20191—
+5K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+5K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+5K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—