510(k) Report

Devices descending from K070364

286 later devices reach 100KGY E-Poly Maxrom Acetabular Liners through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+1K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+1K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+1K080528E-Poly Tibial BearingsBiomet Orthopedics, Inc.2008248—
+1K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+2K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+2K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+2K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+2K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+2K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+2K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201333—
+2K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+2K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+2K113550Vanguard Complete Knee SystemBiomet Manufacturing Corp2012467
+2K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+2K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20101194
+2K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+3K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K222380TriVerse Total Knee Replacement SystemSignature Orthopaedics Pty, Ltd.20221—
+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
+3K210554Physica systemLima Corporate S.P.A.20212—
+3K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+3K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+3K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+3K180493A3 Total Knee SystemBeijing AK Medical Co., Ltd.20181—
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K171054Biomet Knee Joint Replacement ProsthesesBiomet, Inc.201754
+3K161592Persona Partial Knee SystemBiomet, Inc.201652
+3K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+3K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+3K153657Vanguard XP Knee SystemBiomet, Inc.201611
+3K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+3K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K143242Rebel 3DKNEE SystemEncore Medical L.P.20151117
+3K143635KINETIS Total Knee SystemMako Surgical20150—
+3K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+3K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+3K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+3K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+3K131518Mectacer Biolox Option HeadsMedacta International20130—
+3K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+3K130365X-Alt Highly Cross Linked VE Acetabular LinerEncore Medical L.P.201338—
+3K122883Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemStelkast Company201341
+3K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+3K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+3K123692Pipeline Knee SystemPipeline Orthopedics20130—
+3K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+3K123982Turon Glenoid Pegged, E+, Turon Keeled Glenoid, E+Encore Medical L.P.201335—
+3K121727Movation Knee SystemEncore Medical L.P.201214—
+3K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.2012351
+3K103223Highly Cross-Linked Vitamin E Uhmwpe Tibial InsertsEncore Medical L.P.201037—
+3K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+4K261453G7® Acetabular SystemZimmer Biomet20260—
+4K262057GMK ExtensionMedacta International SA20260—
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+4K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+4K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+4K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.20250—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K251834Persona Partial KneeZimmer Biomet20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—