510(k) Report

Devices descending from K023211

293 later devices reach Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd.20172—
+1K140222Saiph Knee SystemMatortho20140—
+1K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+1K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+1K120313Neo CR Knee SystemPipeline Orthopedics20123—
+1K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+1K113122Pipeline CR Primary Knee SystemPipeline Orthopedics20121—
+1K102367Optigen Total Knee SystemU&I Corp.20100—
+1K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+1K060370Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc.200619717
+1K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc.200319324
+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—
+2K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+2K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc.20190—
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+2K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+2K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+2K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+2K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+2K131368Neo Knee SystemPipeline Orthopedics20131—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K122500Neo PS Knee SystemPipeline Orthopedics20131—
+2K122160Vanguard XP Knee SystemBiomet Manufacturing Corp2013612
+2K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+2K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+2K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K121443Journey II CR Knee SystemSmith & Nephew, Inc.201237—
+2K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+2K110240Smith & Nephew, Inc. Sureshot Distal Targeting System V2.1Smith & Nephew, Inc.20112—
+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
+2K071107Gender Solutions Natural-Knee Flex System; Nex Gen Complete Knee Solution CR-Flex Gender…Zimmer, Inc.200705
+2K070695Zimmer Patellofemoral Joint ProsthesisZimmer, Inc.20071225
+2K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc.200712363
+2K043101Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsZimmer, Inc.20055922
+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
+3K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+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—
+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—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+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
+3K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K201084Physica systemLima Corporate S.P.A.20205—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K200122MOTO PFJ SystemMedacta International S.A.20202—
+3K200407LEGION Inserts with JRNY LockSmith & Nephew, Inc.20202—
+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—
+3K173331JOURNEY II XR Knee InstrumentsSmith & Nephew, Inc.201714
+3K170280Smith & Nephew SURESHOT Distal Targeting System V4.0Smith & Nephew, Inc.20170—
+3K153657Vanguard XP Knee SystemBiomet, Inc.201611
+3K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+3K143635KINETIS Total Knee SystemMako Surgical20150—
+3K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+3K142069GMK ExtensionMedacta International20144—
+3K141471Journey II XR Knee SystemSmith & Nephew, Inc.201412—
+3K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+3K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K141585Smith & Nephew Disposable Fin PunchSmith & Nephew, Inc.20140—
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+3K133630GMK Short StemMedacta International20131—
+3K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+3K131310GMK Full PE Tibial ComponentsMedacta International20132—
+3K130748Smith & Nephew Sureshot Distal Targeting System V3.0Smith & Nephew, Inc.20131—
+3K123486Triathlon Tritanium Tibial BaseplateStryker2013517
+3K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+3K121416GMK SphereMedacta International201220—
+3K120790GMK - Line ExtensionMedacta International201211—
+3K113571GMK Resufacing Patella Size 4Medacta International201223—
+3K110950Consensus Knee SystemConsensus Orthopedics, Inc.201114—
+3K111283GMK Revision Hybrid LinersMedacta International20110—
+3K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+3K090988GMK Total Knee SystemMedacta International S.A.2009521
+3K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+3K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20081175