510(k) Report

Devices descending from K003910

205 later devices reach Nexgen Complete Knee Solution Cross-Linked Polyethylene Cruciate Retaining… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K140222Saiph Knee SystemMatortho20140—
+1K013991Prolong Highly Crosslinked Polyethtylene Cruciate Retaining (CR) Articular Surface…Zimmer, Inc.2001203—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K103733United U2 Xpe Total Knee SystemUnited Orthopedic Corporation201182
+2K070214Gender Solutions Natural-Knee Flex SystemZimmer, Inc.200712363
+2K060722Nexgen Complete Knee Solution Ultracongruent (UC-Flex) Fixed Bearing Articular Surface…Zimmer, Inc.200679—
+2K042271Nexgen Complete Knee Solution LPS-Flex Prolong Highly Crosslinked Polyethylene Articular…Zimmer, Inc.2004162
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation20170—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+3K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+3K131310GMK Full PE Tibial ComponentsMedacta International20132—
+3K122500Neo PS Knee SystemPipeline Orthopedics20131—
+3K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+3K113369Zimmer Persona Knee SystemZimmer, Inc.20129639
+3K110950Consensus Knee SystemConsensus Orthopedics, Inc.201114—
+3K102927Consensus Knee SystemConsensus Orthopedics, Inc.20110—
+3K081023Evolis Total Knee SystemMedacta International S.A.2008781
+3K073286Gender Solutions Natural-Knee Flex SystemZimmer, Inc.20081175
+3K071107Gender Solutions Natural-Knee Flex System; Nex Gen Complete Knee Solution CR-Flex Gender…Zimmer, Inc.200705
+4K262057GMK ExtensionMedacta International SA20260—
+4K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251—
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K230078TRAX® CR Total Knee SystemAmplitude20230—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K221479Persona Personalized Knee SystemZimmer, Inc.20228—
+4K222566Zimmer Persona Personalized Knee SystemZimmer, Inc.20222—
+4K213381Physica systemLima Corporate S.P.A.202101
+4K212129Persona® Personalized Knee SystemZimmer Switzerland Manufacturing GmbH20210—
+4K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+4K210062Mectaplug PE IIMedacta International S.A.20210—
+4K200209Persona Personalized Knee SystemZimmer, Inc.20202—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+4K172524Zimmer Persona Personalized Knee SystemZimmer, Inc.201815—
+4K163167CKS Plus Knee SystemConsensus Orthopedics, Inc.20173—
+4K160515PS2 Knee SystemConsensus Orthopedics, Inc.20162—
+4K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+4K143725Consensus Knee System Modular Tibial BaseplateConsensus Orthopedics, Inc.20153—
+4K142787Zimmer Persona Personalized Knee SystemZimmer, Inc.201416—
+4K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+4K142069GMK ExtensionMedacta International20144—
+4K133919Consensus Vitalite Tibial InsertConsensus Orthopedics, Inc.20147—
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K133737Zimmer (R) Persona the Personalized Kee System 14X +30MM Tapered Stem ExtensionZimmer, Inc.20145—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K130143Persona Natural Tibia BaseplatesZimmer, Inc.201321—
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+4K122745Zimmer Persona the Personalized Knee SystemZimmer, Inc.201221—
+4K122765Persona Natural Tibia BaseplatesZimmer, Inc.2012252
+4K121771Zimmer Persona the Personalized Knee SystemZimmer, Inc.2012592
+4K121416GMK SphereMedacta International201220—
+4K120790GMK - Line ExtensionMedacta International201211—
+4K120313Neo CR Knee SystemPipeline Orthopedics20123—
+4K113571GMK Resufacing Patella Size 4Medacta International201223—
+4K112285Milestone Knee System, Femoral Component, Posterior Stablized, Unocated / RLP, Uncoated…Tgm Medical, Inc.20111—
+4K111283GMK Revision Hybrid LinersMedacta International20110—
+4K090988GMK Total Knee SystemMedacta International S.A.2009521
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+5K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260—
+5K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.20260—
+5K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+5K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.20240—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+5K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+5K211664GMK Sphere RevisionMedacta International S.A.20210—
+5K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+5K201611Apex Knee SystemOmnilife Science20210—
+5K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+5K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+5K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+5K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+5K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+5K162035GMK SphereMedacta International S.A.201710—
+5K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+5K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+5K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+5K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+5K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+5K140826GMK Sphere ExtensionMedacta International201417—
+5K133630GMK Short StemMedacta International20131—
+5K131368Neo Knee SystemPipeline Orthopedics20131—