510(k) Report

Devices descending from K926107

481 later devices reach Arcom Polyethylene Acetabular Liners & Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042989RX90 Low Profile Acetabular SystemBiomet, Inc.20051—
+1K023357Arcpm 1050 Resin-HipsBiomet Orthopedics, Inc.20024801
+2K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+2K062997Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsBiomet Manufacturing Corp200602
+2K052255Arcomxl Polyethylene RX90 Acetabular LinersBiomet, Inc.20050—
+2K050327E-Poly (Vitamin E) Acetabular LinersBiomet, Inc.2005289—
+2K042051Arcomxl Polyethylene LinersBiomet, Inc.20053551
+3K160895Initia Total Hip System & BIOCERAM AZUL (R) HEADKyocera Medical Corporation20162—
+3K112898Delta TT Cups, Delta TT Liners, Bone ScrewsLima Corporate S.P.A.201212—
+3K121034Ioi Total HipIconacy Orthopedic Implants, LLC201211—
+3K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+3K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+3K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc.2007165—
+3K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007286—
+3K051411Arcomxl Polyethylene Liners and Biolox Delta HeadsBiomet, Inc.20053441
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K241059Pantheon Proximal Femur Reconstruction (PFR) SystemAdler Ortho S.P.A20250—
+4K243444Bioceram Azul® HeadKyocera Corporation20240—
+4K182099Delta TT ProLima Corporate S.P.A.20183—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+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
+4K141395Delta TT Acetabular SystemLima Corporate S.P.A.2014101
+4K132572I-Hip Total Hip SystemIconacy Orthopedic Implants, LLC20147—
+4K133228Iconacy I-Hip System, Gradual Transitioning (GT) Femoral SystemIconacy Orthopedic Implants, LLC20147—
+4K131279Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC20138—
+4K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+4K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+4K112463United 36MM Ceramic Femoral Head, DeltaUnited Orthopedic Corporation201181
+4K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+4K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+4K090103100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallBiomet, Inc.2009153—
+4K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+4K082844Biolox Delta Ceramic Femoral Head, Biolox Delta Ceramic Femoral Head Offset SleeveEncore Medical L.P.20081651
+4K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+4K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+4K06131236MM Biolox Delta Ceramic HeadsBiomet, Inc.2006343—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K241483ceramys™ femoral head systemEncore Medical L.P.20251—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+5K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+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
+5K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+5K200656Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20200—
+5K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+5K191622Delta Multihole TT Pro Acetabular SystemLima Corporate S.P.A.20192—
+5K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+5K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+5K181171Zimmer Biomet Ceramic HeadsZimmer, Inc.201925
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+5K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+5K170473C2 femoral stemLima Corporate S.P.A.20170—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+5K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+5K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+5K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+5K131518Mectacer Biolox Option HeadsMedacta International20130—
+5K131684Biolox (R) Delta Ceramic HeadsBiomet, Inc.201392
+5K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+5K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+5K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+5K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+5K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+5K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+5K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+5K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+5K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+5K100445Klassic HD Hip SystemTotal Joint Orthopedics, Inc.201025—
+5K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+5K100412Biolox Delta Ceramic Femoral HeadsSmith & Nephew, Inc.2010140—
+5K071535Biolox Delta Ceramic Femoral HeadZimmer, Inc.20072173
+6K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+6K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+6K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K240452Ceramic Femoral HeadMicroport Orthopedics, Inc.20240—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+6K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+6K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+6K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+6K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+6K220483Platform® Acetabular SystemTotal Joint Orthopedics, Inc.20220—
+6K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+6K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+6K213580Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head lengthTotal Joint Othopedics, Inc.20211—
+6K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+6K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—