510(k) Report

Devices descending from K945115

537 later devices reach Mallory-Head Modular Calcar Repacement Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K161226Revision Femoral StemLima Corporate S.P.A.20170—
+5K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+5K162222GENflex2 Total Knee SystemStelkast, Inc.20163—
+5K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+5K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+5K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+5K142606Trident® Tritanium® PST® Acetabular ShellsMako Surgical Corp.20150—
+5K141327Minima S SystemLima Corporate S.P.A.20145—
+5K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+5K140975Mastersl Femoral StemLima Corporate S.P.A.20144—
+5K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+5K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+5K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+5K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+5K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+5K122158PBP Total Hip SystemPipeline Biomedical Products, LLC201221—
+5K121509Treasure Bipolar Head, Femoral Head, Treasure Bipolar Head, InsertTgm Medical, Inc.20120—
+5K121935Taperset Hip Small StemsConsensus Orthopedics, Inc.201220—
+5K121263Taper Set Hip System RDP StemConsensus Orthopedics, Inc.20120—
+5K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+5K111472Helicon Hip System, Femoral Stem, Helicon Hip System, Femoral Head, Cocr, Helicon Hip…Tgm Medical20114—
+5K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+5K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+5K090103100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallBiomet, Inc.2009153—
+5K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+5K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+5K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+5K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+5K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006343—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K231925MINIMA S SystemLima Corporate S.P.A.20230—
+6K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+6K212327M-Vizion MonoblocMedacta International S.A.20221—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K201471M-Vizion Femoral Revision System ExtensionMedacta International S.A.20213—
+6K202484Cordera Hip SystemConformis, Inc.202022
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+6K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K192198Conformis Hip SystemConformis, Inc.2019121
+6K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+6K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+6K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+6K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+6K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+6K143509MasterSL femoral stemLima Corporate S.P.A.20153—
+6K142201OMNI Interface Acetabular SystemOmnlife Science20151—
+6K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+6K131518Mectacer Biolox Option HeadsMedacta International20130—
+6K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+6K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+6K131237Pipeline Total Hip SystemPipeline Orthopedics201320—
+6K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+6K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+6K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+6K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+6K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+6K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+6K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+6K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+6K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+6K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+6K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+6K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+6K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20072173
+7K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+7K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+7K252067Velora Acetabular SystemRestor3D, Inc.20250—
+7K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+7K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+7K231178ACTERA™ hip systemConformis, Inc.20230—
+7K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+7K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+7K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+7K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+7K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+7K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+7K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+7K221104Actera™ hip systemConformis, Inc.202211
+7K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231