510(k) Report

Devices descending from K933281

553 later devices reach S.O.S. Proximal Femur through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+5K172235CoreHip® SystemAesculap Implants Systems, LLC20180—
+5K170753Acculoc Total Knee SystemRootloc Co., Ltd.20183—
+5K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+5K173875GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertStelkast, Inc.20182—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K173104Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…Total Joint Orthopedics, Inc.20176—
+5K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+5K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+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—
+5K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+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—
+5K130673Lospa Total Knee Replacement SystemCorentec Co., Ltd.201392
+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—
+5K121037Lospa Tibial Base PlateCorentec Co., Ltd.201210—
+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—
+6K252451EPORE® XO cup systemImplantcast GmbH20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+6K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+6K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+6K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+6K240834EcoFit® short stem cementless cpTiImplantcast GmbH20241—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.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—
+6K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+6K203420EcoFit® Hip SystemImplantcast GmbH20214—
+6K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+6K202484Cordera Hip SystemConformis, Inc.202022
+6K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+6K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., 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—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+6K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+6K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K182370Acculoc Total Knee SystemRootloc Co., Ltd.20180—
+6K181146ASK SystemL and K Biomed Corporation Limited20180—
+6K170473C2 femoral stemLima Corporate S.P.A.20170—
+6K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+6K160011H-Max S stemLima Corporate S.P.A.20161—
+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—
+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—
+7K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—