510(k) Report

Devices descending from K010101

121 later devices reach Gem Posterior Stabilized Total Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030367Columbus (PS)Aesculap, Inc.2003171
+1K021313Search Evolution Total Knee SystemAesculap, Inc.2002120—
+2K143106VEGA Knee SystemAesculap Implant Systems, LLC20144—
+2K083772Columbus Revision Knee SystemAesculap Implant System, Inc.2009124
+2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+2K071220Columbus Total Knee System asAesculap Implant Systems, Inc.200771
+2K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc.200480—
+2K023788Columbus (CR) Total Knee SystemAesculap, Inc.200225—
+2K022672Columbus Total Knee System (CR)Aesculap, Inc.2002961
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K122985Columbus Revision Knee SystemAesculap Implant System, Inc.201201
+3K101815Enduro Knee SystemAesculap Implant Systems201010—
+3K081023Evolis Total Knee SystemMedacta International S.A.2008781
+3K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc.200818
+3K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc.20076—
+3K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc.20060—
+3K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+3K033260AequosAap Implantate AG200419—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+4K142069GMK ExtensionMedacta International20144—
+4K131167UnivationAesculap Implant Systems, LLC201308
+4K131310GMK Full PE Tibial ComponentsMedacta International20132—
+4K130299GMK HingeMedacta International201342
+4K122975GKS Prime Flex CR Total Knee SystemPermedica20120—
+4K121416GMK SphereMedacta International201220—
+4K120790GMK - Line ExtensionMedacta International201211—
+4K113571GMK Resufacing Patella Size 4Medacta International201223—
+4K111283GMK Revision Hybrid LinersMedacta International20110—
+4K090988GMK Total Knee SystemMedacta International S.A.2009521
+4K091069Medacta Bone Screws - Evolis and VersafitMedacta International S.A.200923—
+5K262057GMK ExtensionMedacta International SA20260—
+5K234044ACS® LD FB Knee SystemImplantcast GmbH20241—
+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—
+5K210062Mectaplug PE IIMedacta International S.A.20210—
+5K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+5K201084Physica systemLima Corporate S.P.A.20205—
+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—
+5K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+5K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+5K162035GMK SphereMedacta International S.A.201710—
+5K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+5K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+5K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+5K140826GMK Sphere ExtensionMedacta International201417—
+5K133630GMK Short StemMedacta International20131—
+5K123721GMK Revision ExtensionMedacta International20133—
+5K122232GMK NarrowMedacta International20128—
+5K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+5K103721Mpact Acetabular SystemMedacta International201121—
+5K103352Versafitcup CC TrioMedacta International20114—
+5K102437GMK Revision Knee SystemMedacta International S.A.201034—
+5K093806Myknee Cutting BlocksMedacta International S.A.201016—
+6K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K250450Coated hip implantsMedacta International S.A.20250—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+6K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K231037MyKnee UNI-STMedacta International S.A.20230—
+6K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K213381Physica systemLima Corporate S.P.A.202101
+6K211938Physica LMC Knee SystemLimacorporate20210—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K210554Physica systemLima Corporate S.P.A.20212—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K193559NextAR TKA PlatformMedacta Inernational SA202012—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+6K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+6K143453Mpact Double Mobility SystemMedacta International20151—
+6K132879Mpact ExtensionMedacta International201411—
+6K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+6K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+6K131458Mpact DM Liner ConverterMedacta International20133—
+6K122911Versafitcup CC Trio ExtensionMedacta International20121—
+6K122641Mpact ExtensionMedacta International201214—
+6K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+6K111145Endo HeadMedacta International20110—
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—