510(k) Report

Devices descending from K960279

312 later devices reach Nexgen Compl. Knee Sol. Legacy Posterior Stabilized/Constrained Condylar Knee… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+3K222700Tibial baseplate, Tibial insertUnited Orthopedic Corporation20220—
+3K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+3K211664GMK Sphere RevisionMedacta International S.A.20210—
+3K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+3K200765Genius / Genuin Total Knee SystemBiorad Medisys Pvt, Ltd.20210—
+3K210062Mectaplug PE IIMedacta International S.A.20210—
+3K210551Persona Revision Knee SystemZimmer, Inc.202101
+3K201084Physica systemLima Corporate S.P.A.20205—
+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—
+3K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+3K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+3K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192—
+3K183533Unity Total Knee SystemCorin U.S.A. Limited20191—
+3K190068Vanguard XP Knee SystemZimmer, Inc.20190—
+3K183583Vanguard Complete Knee SystemZimmer, Inc.20191—
+3K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+3K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+3K173417Zimmer Persona Personalized Knee SystemZimmer, Inc.20189—
+3K173884Unity Total Knee SystemCorin U.S.A. Limited20182—
+3K170808Unity Total Knee SystemCorin U.S.A. Limited20170—
+3K162035GMK SphereMedacta International S.A.201710—
+3K153657Vanguard XP Knee SystemBiomet, Inc.201611
+3K152430All Poly Tibial ComponentUnited Orthopedic Corporation20160—
+3K152252Arthrex iBalance TKA SystemArthrex, Inc.20152—
+3K150829U2 Total Knee System- Additional SizesUnited Orthopedic Corporation20153—
+3K150090Zimmer Persona Personalized Knee SystemZimmer, Inc.201517—
+3K143635KINETIS Total Knee SystemMako Surgical20150—
+3K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+3K143106VEGA Knee SystemAesculap Implant Systems, LLC20144—
+3K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+3K141407Vanguard XP Femoral Component (Gen II)/Vanguard XP Femoral TrialBiomet, Inc.201421
+3K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+3K140826GMK Sphere ExtensionMedacta International201417—
+3K140257Signature Planner, Signature GuidesMaterialise NV20140—
+3K133630GMK Short StemMedacta International20131—
+3K132873Vanguard XP Knee SystemBiomet, Inc.2013322
+3K130299GMK HingeMedacta International201342
+3K123721GMK Revision ExtensionMedacta International20133—
+3K122500Neo PS Knee SystemPipeline Orthopedics20131—
+3K123486Triathlon Tritanium Tibial BaseplateStryker2013517
+3K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+3K122232GMK NarrowMedacta International20128—
+3K111970Kneetec PFJ&HLS Kneetec Patellar ComponentTornier20120—
+3K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K103352Versafitcup CC TrioMedacta International20114—
+3K102437GMK Revision Knee SystemMedacta International S.A.201034—
+3K093806Myknee Cutting BlocksMedacta International S.A.201016—
+3K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779—
+3K071220Columbus Total Knee System asAesculap Implant Systems, Inc.200771
+3K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc.200480—
+3K023788Columbus (CR) Total Knee SystemAesculap, Inc.200225—
+3K022672Columbus Total Knee System (CR)Aesculap, Inc.2002961
+4K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts20260—
+4K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+4K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.20260—
+4K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+4K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+4K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+4K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K250889EXULT Knee Replacement SystemCorentec Co., Ltd.20250—
+4K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+4K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+4K231037MyKnee UNI-STMedacta International S.A.20230—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+4K211938Physica LMC Knee SystemLimacorporate20210—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K210961U2 Total Knee System, XPE Tibial Insert, PS PLUSUnited Orthopedic Corporation20210—
+4K210554Physica systemLima Corporate S.P.A.20212—
+4K201611Apex Knee SystemOmnilife Science20210—
+4K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized…Depuy Ireland UC202041
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K191084The Optimotion Blue Total Knee SystemOptimotion Implants, LLC20201—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.)201911—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K182346TRULIANT Porous Tibial Tray and Exactech Alteon Bone ScrewsExactech, Inc.20185—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K171365Arthrex Knee SystemsArthrex, Inc.20170—
+4K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+4K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics2017241
+4K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+4K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+4K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.20160—
+4K153721iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.20160—
+4K160025iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR)…Conformis, Inc.2016201
+4K153586Arthrex iBalance TKA SystemArthrex, Inc.20161—
+4K153217ConforMIS iTotal Posterior Stabilized Knee Replacement SystemConformis, Inc.201618—
+4K152704iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee…Conformis, Inc.201523—