510(k) Report

Devices descending from K933785

328 later devices reach Next Generation Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181947Persona Revision Knee SystemZimmer, Inc.201841
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd.20172—
+1K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc.20153—
+1K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+1K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+1K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+1K103756Depuy Attune Total Knee SystemDePuy Orthopaedics, Inc.20117—
+1K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010114—
+1K102367Optigen Total Knee SystemU&I Corp.20100—
+1K072281Nexgen Prolong All-Poly PatellaZimmer, Inc.200797—
+1K052879Nexgen Complete Knee Solution Mis Modular Tibial Plates and KeelsZimmer, Inc.20056—
+1K043101Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsZimmer, Inc.20055922
+1K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc.200319324
+1K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsZimmer, Inc.20022936
+2K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+2K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc.20260—
+2K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+2K242665DePuy ATTUNE™ Total Knee SystemDepuy Orthopedics, Inc.20240—
+2K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+2K230078TRAX® CR Total Knee SystemAmplitude20230—
+2K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+2K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+2K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+2K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+2K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+2K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+2K201347DePuy ATTUNE™ Total Knee SystemDePuy Orthopaedics, Inc.20200—
+2K200122MOTO PFJ SystemMedacta International S.A.20202—
+2K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UC20200—
+2K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+2K193057ATTUNE All-Polyethylene TibiaDepuy Ireland UC20200—
+2K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+2K192507LOSPA II Knee SystemCorentec Co., Ltd.20197—
+2K191779Attune Revision LPS InsertsDepuy (Ireland)201904
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc.20190—
+2K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+2K170806ATTUNE Cemented Tibial Base, Fixed BearingDepuy (Ireland)201721
+2K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+2K140881Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsDepuy (Ireland)2015310
+2K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+2K140222Saiph Knee SystemMatortho20140—
+2K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+2K133630GMK Short StemMedacta International20131—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+2K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+2K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+2K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+2K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K120313Neo CR Knee SystemPipeline Orthopedics20123—
+2K113122Pipeline CR Primary Knee SystemPipeline Orthopedics20121—
+2K111433Depuy Sttune (TM) PS Knee SystemDePuy Orthopaedics, Inc.2011391
+2K103733United U2 Xpe Total Knee SystemUnited Orthopedic Corporation201182
+2K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+2K090988GMK Total Knee SystemMedacta International S.A.2009521
+2K081023Evolis Total Knee SystemMedacta International S.A.2008781
+2K072619Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Zimmer, Inc.20071024
+2K072160Nexgen Trabecular Metal Tibial TrayZimmer, Inc.20071081
+2K060370Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc.200619717
+2K041100Nexgen Porous, HA/TCP, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc.200463
+2K042271Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular…Zimmer, Inc.2004162
+3K262057GMK ExtensionMedacta International SA20260—
+3K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+3K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC20260—
+3K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+3K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+3K242401EXULT Knee Replacement SystemCorentec Co., Ltd.20240—
+3K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+3K242046EXULT Knee Replacement SystemCorentec Co., Ltd.20242—
+3K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K233980ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…Depuy Ireland UC20240—
+3K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+3K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K222278LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationCorentec Co., Ltd.20220—
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+3K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+3K213381Physica systemLima Corporate S.P.A.202101
+3K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+3K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+3K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+3K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—