510(k) Report

Devices descending from K070399

165 later devices reach 100KGY E-Poly Acetabular Liners-Additional Profiles through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+1K100048E1 Antioxidant Infused TechnologyBiomet Manufacturing Corp2010114—
+1K09354944MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumBiomet Manufacturing Corp200960—
+1K090103100KGY E-Poly Acetabular Liners- Additional Profiles: +3 Maxrom and +3 HI-WallBiomet, Inc.2009153—
+1K073102Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersBiomet Manufacturing Corp2007163—
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K141653Biolox Delta Ceramic Option HeadsBiomet, Inc.20144—
+2K131518Mectacer Biolox Option HeadsMedacta International20130—
+2K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+2K121874G7 Acetabular SystemBiomet Manufacturing Corp2012533
+2K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+2K112897Renovis Surgical Hip Joint Replacement ProsthesisRenovis Surgical Technologies, LLC20128—
+2K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+2K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+2K082996Biolox Delta Option Ceramic HeadsBiomet, Inc.2009614
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, 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
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K212512G7® Vivacit-E® Freedom® Constrained LinerZimmer, Inc.20220—
+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
+3K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+3K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsBiomet UK, Ltd.20202—
+3K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+3K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+3K183457Zimmer Biomet 12/14 CoCr Femoral Head and Freedom HeadZimmer, Inc.20190—
+3K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+3K190057DJO Acetabular SystemEncore Medical L.P.201925
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K182321MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20198—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K182221Bencox Mirabo Cup Multi HoleCorentec Co., Ltd.20193—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K181761Zimmer Biomet Select Ceramic HeadsZimmer, Inc.20180—
+3K181947Persona Revision Knee SystemZimmer, Inc.201841
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+3K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+3K171543Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies20170—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K161592Persona Partial Knee SystemBiomet, Inc.201652
+3K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+3K142882G7 Freedom and Offset Liners, Freedom Head, Size 32Biomet, Inc.201517—
+3K142746G7 Finned Acetabular ShellBiomet Manufactuting Corp.20140—
+3K140669G7 Osseoti Acetublar ShellsBiomet, Inc.201435—
+3K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+3K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+3K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K261453G7® Acetabular SystemZimmer Biomet20260—
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+4K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K252623G7® Revision Acetabular SystemZimmer, Inc.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+4K251834Persona Partial KneeZimmer Biomet20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+4K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+4K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+4K243809Biolox® Delta Revision headsLimacorporate20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K241636MobileLink Acetabular Cup System - Line Extension (Multiple)Waldemar Link GmbH & Co. KG20242—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+4K210614BENCOX Mirabo Z Cup CortiniumCorentec Co., Ltd.20221—
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+4K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingBiomet UK, Ltd.20200—
+4K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—