510(k) Report

Devices descending from K060370

197 later devices reach Nexgen Knee Gender Solutions Female (GSF) Femoral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+1K072619Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Zimmer, Inc.20071024
+1K071107Gender Solutions Natural-Knee Flex System; Nex Gen Complete Knee Solution CR-Flex Gender…Zimmer, Inc.200705
+1K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc.20071225
+1K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc.200712363
+2K230078TRAX® CR Total Knee SystemAmplitude20230—
+2K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+2K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+2K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+2K200122MOTO PFJ SystemMedacta International S.A.20202—
+2K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+2K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+2K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+2K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+2K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+2K131310GMK Full PE Tibial ComponentsMedacta International20132—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K122500Neo PS Knee SystemPipeline Orthopedics20131—
+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
+2K110950Consensus Knee SystemConsensus Orthopedics, Inc.201114—
+2K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+2K081023Evolis Total Knee SystemMedacta International S.A.2008781
+2K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20081175
+3K262057GMK ExtensionMedacta International SA20260—
+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—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+3K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+3K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+3K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+3K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+3K213381Physica systemLima Corporate S.P.A.202101
+3K213071MOTOTM Partial Knee & MOTO PFJ Systems ExtensionMedacta International S.A.20211—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K210062Mectaplug PE IIMedacta International S.A.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+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—
+3K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+3K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+3K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc.20153—
+3K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+3K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+3K142069GMK ExtensionMedacta International20144—
+3K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147—
+3K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+3K121416GMK SphereMedacta International201220—
+3K120790GMK - Line ExtensionMedacta International201211—
+3K120313Neo CR Knee SystemPipeline Orthopedics20123—
+3K113571GMK Resufacing Patella Size 4Medacta International201223—
+3K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111—
+3K111283GMK Revision Hybrid LinersMedacta International20110—
+3K090988GMK Total Knee SystemMedacta International S.A.2009521
+3K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+4K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+4K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+4K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K251618MOTO Partial Knee System ExtensionMedacta International S.A.20250—
+4K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+4K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+4K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+4K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+4K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+4K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+4K171365Arthrex Knee SystemsArthrex, Inc.20170—
+4K162035GMK SphereMedacta International S.A.201710—
+4K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+4K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201