510(k) Report

Devices descending from K000666

115 later devices reach TC-Plus Solution Knee through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp.2009421
+1K072858TC-Plus Primary Knee SystemSmith & Nephew, Inc.20075315
+1K023416Modification to VKS Knee SystemPlus Orthopedics20020—
+1K022204VKS Knee SystemPlus Orthopedics2002704
+1K011258TC-Plus Porous Femoral ComponentsPlus Orthopedics200154—
+2K152169Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial InsertsOrtho Development Corporation20151—
+2K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+2K113482Journey II Deep Dished Articular InsertsSmith & Nephew, Inc.20126—
+2K112906Klassic Knee SystemTotal Joint Orthopedics, Inc.201233—
+2K090988GMK Total Knee SystemMedacta International S.A.2009521
+2K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc.20060—
+2K032215VKS/TC-Plus Revision KneePlus Orthopedics20036—
+3K262057GMK ExtensionMedacta International SA20260—
+3K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+3K243991Klassic Knee System - Revision Tibial BaseplateTotal Joint Othopedics, Inc.20251—
+3K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+3K232414Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-PostTotal Joint Othopedics, Inc.20230—
+3K230537Klassic Knee Revision SystemTotal Joint Othopedics, Inc.20232—
+3K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+3K211671Journey II Mid-Level Tibial InsertsSmith & Nephew, Inc.20211—
+3K211602Klassic Knee SystemTotal Joint Orthopedics, Inc.20210—
+3K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.20203—
+3K202022GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS…Medacta International S.A.20201—
+3K183596Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post…Total Joint Orthopedics, Inc.20192—
+3K180159Klassic® Knee SystemTotal Joint Orthopedics, Inc.201822—
+3K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+3K162422Klassic Knee SystemTotal Joint Orthopedics, Inc.201623—
+3K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+3K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+3K153310Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K153075Klassic Knee SystemTotal Joint Orthopedics, Inc.201524—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K150105Klassic Knee System-Sombrero PatellaTotal Joint Orthopedics, Inc.201524—
+3K142069GMK ExtensionMedacta International20144—
+3K140826GMK Sphere ExtensionMedacta International201417—
+3K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc.201427—
+3K133630GMK Short StemMedacta International20131—
+3K131310GMK Full PE Tibial ComponentsMedacta International20132—
+3K123721GMK Revision ExtensionMedacta International20133—
+3K122232GMK NarrowMedacta International20128—
+3K121416GMK SphereMedacta International201220—
+3K120790GMK - Line ExtensionMedacta International201211—
+3K113571GMK Resufacing Patella Size 4Medacta International201223—
+3K111283GMK Revision Hybrid LinersMedacta International20110—
+3K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+3K102437GMK Revision Knee SystemMedacta International S.A.201034—
+3K093806Myknee Cutting BlocksMedacta International S.A.201016—
+3K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+4K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+4K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+4K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+4K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+4K231037MyKnee UNI-STMedacta International S.A.20230—
+4K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+4K211877Klassic Knee SystemTotal Joint Orthopedics, Inc.20221—
+4K211664GMK Sphere RevisionMedacta International S.A.20210—
+4K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+4K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+4K210062Mectaplug PE IIMedacta International S.A.20210—
+4K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K202740Klassic Knee System Tibial Inserts, PS-MaxTotal Joint Orthopedics, Inc.20200—
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+4K190280Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System -…Total Joint Orthopedics, Inc.20190—
+4K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+4K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+4K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+4K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+4K162035GMK SphereMedacta International S.A.201710—
+4K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+4K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+4K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+4K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+5K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+5K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+5K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K202152NextAR TKA PlatformMedacta International S.A.202011—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+6K250477NextAR (TM) SpineMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—