510(k) Report

Devices descending from K100048

114 later devices reach E1 Antioxidant Infused Technology through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132—
+1K122529Zimmer Unicompartmental Knee System Vivacit-E Articular SurfaceZimmer, Inc.201215—
+1K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+1K120370Vivacit-E Vitamin E Highly Crosslinked Polyethylene LinersZimmer, Inc.201288—
+1K101336E1 Avantage HeadBiomet Manufacturing Corp2011241
+2K243295Initia Knee SystemKyocera Medical Technologies, Inc.20250—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+2K200823Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.202011
+2K190656Dual Mobility - Longevity and Vivacit-E Polyethylene Hip BearingsZimmer, Inc.201913
+2K190660G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System…Zimmer, Inc.20194—
+2K190122Renovis A200 PS Knee System as part of the Renovis A200 Knee SystemRenovis Surgical Technologies20191—
+2K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+2K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K173380b-ONE® Total Hip SystemB-One Ortho, Corp.20180—
+2K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+2K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+2K161592Persona Partial Knee SystemBiomet, Inc.201652
+2K160738ZUK Select Knee SystemSmith & Nephew, Inc.20168—
+2K161190G7 Dual Mobility System, Active Articulation SystemBiomet, Inc.20167—
+2K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+2K150522G7 Dual Mobility SystemBiomet, Inc.2015211
+2K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+2K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+2K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+2K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+2K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+3K261453G7® Acetabular SystemZimmer Biomet20260—
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+3K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+3K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K251834Persona Partial KneeZimmer Biomet20250—
+3K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+3K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+3K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+3K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+3K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+3K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+3K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+3K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+3K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+3K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+3K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+3K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+3K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+3K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+3K191625Persona Revision Knee SystemZimmer, Inc.201911
+3K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+3K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+3K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+3K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+3K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+3K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+4K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+4K261609Freedom Partial Knee SystemMaxx Orthopedics, 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—
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+4K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+4K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+4K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+4K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+4K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+4K230078TRAX® CR Total Knee SystemAmplitude20230—
+4K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+4K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+4K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+4K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K210551Persona Revision Knee SystemZimmer, Inc.202101
+4K201084Physica systemLima Corporate S.P.A.20205—
+4K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+4K191831MobiliT CupCorin U.S.A. Limited20203—
+4K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+4K192450Precision Casting Solutions Total Hip SystemPrecision Casting Solution, LLC20190—
+4K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+4K190535BiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG201931
+5K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—