510(k) Report

Devices descending from K042051

355 later devices reach Arcomxl Polyethylene Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+1K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+1K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+1K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+1K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+1K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+1K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20053441
+2K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+2K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+2K243444Bioceram Azul® HeadKyocera Corporation20240—
+2K182099Delta TT ProLima Corporate S.P.A.20183—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K160266ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20160—
+2K151307ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC20166—
+2K150855H-MAX S Femoral Hip SystemLima Corporate S.P.A.20152—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+2K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+2K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+2K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+2K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+2K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+2K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+2K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+2K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006343—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+3K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+3K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+3K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K160011H-Max S stemLima Corporate S.P.A.20161—
+3K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+3K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+3K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K131518Mectacer Biolox Option HeadsMedacta International20130—
+3K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+3K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+3K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+3K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+3K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20072173
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+4K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+4K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+4K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+4K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+4K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K192416BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head SystemZimmer GmbH20192—
+4K191399BIOLOX CONTOURA Ceramic Femoral HeadTotal Joint Othopedics, Inc.20190—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+4K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+4K180929Klassic HD® Hip SystemTotal Joint Orthopedics, Inc.20185—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163577Ecofit® Hip SystemImplantcast GmbH201791
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K171962Klassic HD® Hip SystemTotal Joint Othopedics, Inc.20170—
+4K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc.20166—
+4K150576TGM Biolox delta Ceramic HeadsTgm Medical, Inc.20150—
+4K151440Klassic HD Hip SystemTotal Joint Orthopedics, Inc.20151—
+4K150007Modified Bencox Hip SystemCorentec Co., Ltd.20157—
+4K143113Klassic BiPolar SystemTotal Joint Orthopedics201501
+4K143407Klassic HD Hip SystemTotal Joint Othopedics, Inc.201416—
+4K141972Klassic HD Acetabular Insert with E-Link PolyTotal Joint Orthopedics, Inc.201414—
+4K141327Minima S SystemLima Corporate S.P.A.20145—
+4K133832Klassic HD Hip System, Offset Femoral Stem, Non-Porous / PorousTotal Joint Orthopedics, Inc.20142—
+4K131454Klassic HD (TM) Extended Offset Femoral HeadTotal Joint Orthopedics, Inc.20142—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302