510(k) Report

Devices descending from K991581

348 later devices reach Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230120KeYi Total Knee SystemBeijing Keyi Medical Device Technology Co., Ltd.20240—
+1K191192SurgTech GENOLL Total Knee SystemSurgtech, Inc.20190—
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+1K131310GMK Full PE Tibial ComponentsMedacta International20132—
+1K122500Neo PS Knee SystemPipeline Orthopedics20131—
+1K123457Balanced Knee System High Flex PSOrtho Development Corp.20134—
+1K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+1K094013HLS Kneetec SystemTornier20111—
+1K081023Evolis Total Knee SystemMedacta International S.A.2008781
+1K081127Accin Total Knee SystemAccelerated Innovation, LLC2008251
+1K062768Nexgen Complete Knee Solution Legacy Posterior Stabilized Flex Fixed Bearing and…Zimmer, Inc.200625—
+1K060370Nexgen Knee Gender Solutions Female (GSF) Femoral ComponentsZimmer, Inc.200619717
+1K042515Smith & Nephew, Inc. High Performance KneeSmith & Nephew, Inc.20051183
+1K043101Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem ExtensionsZimmer, Inc.20055922
+1K042271Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular…Zimmer, Inc.2004162
+1K032295Genesis II Posterior Stabilized High Flexion Articular InsertSmith & Nephew, Inc.2003766
+1K023211Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral ComponentsZimmer, Inc.20022936
+1K013906HLS Noetos SystemTornier20023—
+2K262057GMK ExtensionMedacta International SA20260—
+2K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+2K230078TRAX® CR Total Knee SystemAmplitude20230—
+2K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+2K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+2K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+2K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+2K221939Cemented Round Patella with JRNY PegsSmith & Nephew, Inc.20220—
+2K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+2K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+2K210062Mectaplug PE IIMedacta International S.A.20210—
+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—
+2K170534Prolixus Total Knee SystemOtis Biotech Co., Ltd.20172—
+2K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+2K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+2K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+2K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+2K152382Arthrex iBalance TKA SystemArthrex, Inc.20152—
+2K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+2K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+2K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+2K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+2K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+2K142069GMK ExtensionMedacta International20144—
+2K143047Arthrex iBalance Patella Implant, DomeArthrex, Inc.20142—
+2K140222Saiph Knee SystemMatortho20140—
+2K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+2K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+2K133854Arthrex Ibalance Tka SystemArthrex, Inc.20144—
+2K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+2K133630GMK Short StemMedacta International20131—
+2K133342Arthrex Ibalance Tka SystemArthrex, Inc.20130—
+2K131337Balanced Knee System High Flex Vitamin E PS Tibial Insert and PatellaOrtho Development Corp.20133—
+2K123692Pipeline Knee SystemPipeline Orthopedics20130—
+2K123159Smith & Newphew, Inc. Disposable Knee InstrumentsSmith & Nephew, Inc.20132—
+2K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+2K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+2K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+2K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+2K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+2K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+2K121393Smith & Nephew, Inc. Total Knee System InstrumentationSmith & Nephew, Inc.201254
+2K121416GMK SphereMedacta International201220—
+2K120790GMK - Line ExtensionMedacta International201211—
+2K120313Neo CR Knee SystemPipeline Orthopedics20123—
+2K113122Pipeline CR Primary Knee SystemPipeline Orthopedics20121—
+2K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+2K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier20120—
+2K113571GMK Resufacing Patella Size 4Medacta International201223—
+2K111711Journey II BCS Knee SystemSmith & Nephew, Inc.2011403
+2K111283GMK Revision Hybrid LinersMedacta International20110—
+2K110837Revision ProthesisSmith & Nephew, Inc.20110—
+2K102367Optigen Total Knee SystemU&I Corp.20100—
+2K094050Itotal CR Knee Replacement SystemConformis, Inc.201041—
+2K101499Journey CR Knee SystemSmith & Nephew, Inc.201045—
+2K101032Cardo Medical Femoral Cement Restrictor, Model 503-MCRXCardo Medical, Inc.20100—
+2K092803Cardo Medical Align 360 Medialized Patella ComponentCardo Medical Corp.20090—
+2K091014Journey BCS Knee SystemSmith & Nephew, Inc.200941—
+2K090988GMK Total Knee SystemMedacta International S.A.2009521
+2K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+2K072619Nexgen Complete Knee Solution LPS-Flex and Knee Gender Solutions Female (GSF) Porous…Zimmer, Inc.20071024
+2K071071Crosslinked Polyethylene Articular InsertsSmith & Nephew, Inc.2007665
+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
+2K041825Smith & Nephew Genesis II Deep Flexion Cruciate Retaining Articular InsertSmith & Nephew, Inc.200575—
+2K031061Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc.200319324
+2K032079HLS Noetos SystemTornier20030—
+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—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, 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—
+3K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+3K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—