510(k) Report

Devices descending from K081023

78 later devices reach Evolis Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142069GMK ExtensionMedacta International20144—
+1K131310GMK Full PE Tibial ComponentsMedacta International20132—
+1K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+1K121416GMK SphereMedacta International201220—
+1K120790GMK - Line ExtensionMedacta International201211—
+1K113571GMK Resufacing Patella Size 4Medacta International201223—
+1K111283GMK Revision Hybrid LinersMedacta International20110—
+1K090988GMK Total Knee SystemMedacta International S.A.2009521
+1K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+2K262057GMK ExtensionMedacta International SA20260—
+2K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+2K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+2K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+2K211664GMK Sphere RevisionMedacta International S.A.20210—
+2K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+2K210062Mectaplug PE IIMedacta International S.A.20210—
+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—
+2K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+2K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+2K162035GMK SphereMedacta International S.A.201710—
+2K140826GMK Sphere ExtensionMedacta International201417—
+2K133630GMK Short StemMedacta International20131—
+2K123721GMK Revision ExtensionMedacta International20133—
+2K122232GMK NarrowMedacta International20128—
+2K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+2K103721Mpact Acetabular SystemMedacta International201121—
+2K103352Versafitcup CC TrioMedacta International20114—
+2K102437GMK Revision Knee SystemMedacta International S.A.201034—
+2K093806Myknee Cutting BlocksMedacta International S.A.201016—
+3K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+3K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K241461Mpact Constrained LinerMedacta International S.A.20251—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+3K230011Mpact ExtensionMedacta International S.A.20233—
+3K231037MyKnee UNI-STMedacta International S.A.20230—
+3K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+3K200391MPACT ExtensionMedacta International S.A.20210—
+3K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K193559NextAR TKA PlatformMedacta Inernational SA202012—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K183582MPACT ExtensionMedacta International S.A.20194—
+3K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+3K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+3K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+3K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+3K143453Mpact Double Mobility SystemMedacta International20151—
+3K132879Mpact ExtensionMedacta International201411—
+3K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+3K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+3K131458Mpact DM Liner ConverterMedacta International20133—
+3K122911Versafitcup CC Trio ExtensionMedacta International20121—
+3K122641Mpact ExtensionMedacta International201214—
+3K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+3K111145Endo HeadMedacta International20110—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.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—
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+4K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+4K211891DM Converter - TiN coatedMedacta International S.A.20220—
+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—
+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—