510(k) Report

Devices descending from K050327

289 later devices reach E-Poly (Vitamin E) Acetabular Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+1K070399100KGY E-Poly Acetabular Liners-Additional ProfilesBiomet Manufacturing, Inc.2007165—
+1K070364100KGY E-Poly Maxrom Acetabular LinersBiomet, Inc.2007286—
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+2K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+2K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+2K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+2K090103100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallBiomet, Inc.2009153—
+2K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+2K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+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
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+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—
+3K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+3K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+3K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+3K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+3K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+3K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+3K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+3K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+3K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+3K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+4K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K210554Physica systemLima Corporate S.P.A.20212—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K201084Physica systemLima Corporate S.P.A.20205—
+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—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+4K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+4K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+4K190057DJO Acetabular SystemEncore Medical L.P.201925
+4K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+4K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+4K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+4K181947Persona Revision Knee SystemZimmer, Inc.201841
+4K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+4K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+4K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+4K161592Persona Partial Knee SystemBiomet, Inc.201652
+4K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+4K153657Vanguard XP Knee SystemBiomet, Inc.201611
+4K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+4K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+4K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+4K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+4K143635KINETIS Total Knee SystemMako Surgical20150—
+4K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+4K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+4K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+4K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+4K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+4K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+4K140257Signature Planner, Signature GuidesMaterialise NV20140—
+4K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+4K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+4K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+4K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+4K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341