510(k) Report

Devices descending from K021657

92 later devices reach Uknee Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103733United U2 Xpe Total Knee SystemUnited Orthopedic Corporation201182
+1K102367Optigen Total Knee SystemU&I Corp.20100—
+1K090988GMK Total Knee SystemMedacta International S.A.2009521
+1K051640U2 Total Knee SystemUnited Orthopedic Corp.2006381
+2K262057GMK ExtensionMedacta International SA20260—
+2K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+2K230850United Orthopedic Knee Patient Specific InstrumentationEnhatch, Inc.20230—
+2K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+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—
+2K170753Acculoc Total Knee SystemRootloc Co., Ltd.20183—
+2K161705U2 Total Knee System E-XPE productsUnited Orthopedic Corporation20171—
+2K161360U2 Total Knee System, PSA Tibial InsertUnited Orthopedic Corporation20170—
+2K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+2K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+2K142649Progressive Orthopedic Total Knee SystemThe Progressive Orthopaedic Company, LLC201510—
+2K142069GMK ExtensionMedacta International20144—
+2K140826GMK Sphere ExtensionMedacta International201417—
+2K140073U2 Femoral Component, CR, CementedUnited Orthopedic Corp.20144—
+2K140075U2 Femoral Component, CR, Porous CoatedUnited Orthopedic Corp.20143—
+2K132752Ultracongruent InsertUnited Orthopedic Corporation20145—
+2K131864U2 Tibial Baseplate- Cma Type, Tibial Insert and AugmentUnited Orthopedic Corporation20145—
+2K133630GMK Short StemMedacta International20131—
+2K131398Novoknee Total Knee SystemNovosource, Inc.201310—
+2K131310GMK Full PE Tibial ComponentsMedacta International20132—
+2K123721GMK Revision ExtensionMedacta International20133—
+2K123339TK1 Total Knee SystemNovosource, Inc.201311—
+2K122232GMK NarrowMedacta International20128—
+2K121416GMK SphereMedacta International201220—
+2K120790GMK - Line ExtensionMedacta International201211—
+2K120507United U2 Femoral Component, PS, #7United Orthopedic Corporation201241
+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—
+2K082424United U2 Total Knee SystemUnited Orthopedic Corp.2008152
+2K082469United U2 PatellaUnited Orthopedic Corp.20080—
+3K261032NovoKnee (SteriKnee)NovoSource20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+3K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation20250—
+3K242410NextStep Arthropedix Total Knee SystemNextstep Arthropedix20250—
+3K231975PNK Total Knee SystemTjc Life Co., Ltd.20230—
+3K231037MyKnee UNI-STMedacta International S.A.20230—
+3K221705U2 Total Knee System-PF+United Orthopedic Corporation20231—
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K210695CPM Medical Consultants Tibial Revision Knee SystemCpm Medical Consultants, LLC20210—
+3K211664GMK Sphere RevisionMedacta International S.A.20210—
+3K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+3K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+3K210062Mectaplug PE IIMedacta 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—
+3K190100USTAR II SystemUnited Orthopedic Corporation201925
+3K190355Precision Casting Solutions Total Knee SystemPrecision Casting Solutions, Inc.20190—
+3K183344The Progressive Orthopaedic Company Total Knee System IIThe Progressive Orthopaedic Company, LLC20190—
+3K183225Stabil Orthopaedic Solutions Total Knee SystemStabil Orthopaedic Solutions, LLC20190—
+3K182370Acculoc Total Knee SystemRootloc Co., Ltd.20180—
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+3K181146ASK SystemL and K Biomed Corporation Limited20180—
+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—
+3K150832U2 Femoral Component, CR, Porous Coated, Additional SizesUnited Orthopedic Corporation20152—
+3K150783Progressive Orthopaedic Total Knee SystemThe Progressive Orthopaedic Company, LLC20158—
+3K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+3K122183Augment and Screw, Psa TypeUnited Orthopedic Corp.201310—
+3K100981United Stem, Psa TypeUnited Orthopedic Corp.20103—
+4K252847NextAR Hip PlatformMedacta International S.A.20260—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K252303Stem Extension Line (USTAR II System)United Orthopedic Corporation20250—
+4K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation20250—
+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—