510(k) Report

Devices descending from K043101

59 later devices reach Nexgen Complete Knee Solution Mis Tibial Components, Locking Screw and Stem… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173057Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.201852
+1K133630GMK Short StemMedacta International20131—
+1K090988GMK Total Knee SystemMedacta International S.A.2009521
+2K262057GMK ExtensionMedacta International SA20260—
+2K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+2K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+2K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+2K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+2K191625Persona Revision Knee SystemZimmer, Inc.201911
+2K181947Persona Revision Knee SystemZimmer, Inc.201841
+2K142069GMK ExtensionMedacta International20144—
+2K140826GMK Sphere ExtensionMedacta International201417—
+2K131310GMK Full PE Tibial ComponentsMedacta International20132—
+2K123721GMK Revision ExtensionMedacta International20133—
+2K122232GMK NarrowMedacta International20128—
+2K121416GMK SphereMedacta International201220—
+2K120790GMK - Line ExtensionMedacta International201211—
+2K113571GMK Resufacing Patella Size 4Medacta International201223—
+2K111283GMK Revision Hybrid LinersMedacta International20110—
+2K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+2K102437GMK Revision Knee SystemMedacta International S.A.201034—
+2K093806Myknee Cutting BlocksMedacta International S.A.201016—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+3K243724Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components)Zimmer, Inc.20250—
+3K231037MyKnee UNI-STMedacta International S.A.20230—
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K211664GMK Sphere RevisionMedacta International S.A.20210—
+3K210829Persona Revision Knee System Femoral Metaphyseal ConesZimmer, Inc.20210—
+3K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+3K210062Mectaplug PE IIMedacta International S.A.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K193559NextAR TKA PlatformMedacta Inernational SA202012—
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+3K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+3K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+3K162035GMK SphereMedacta International S.A.201710—
+3K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+3K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+4K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+4K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+4K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+4K210153NextAR RSA PlatformMedacta International S.A.202151
+4K202152NextAR TKA PlatformMedacta International S.A.202011—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+5K250477NextAR (TM) SpineMedacta International S.A.20250—
+5K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+5K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+5K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+6K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+6K233172NextAR™ Spine PlatformMedacta International S.A.20241—