510(k) Report

Devices descending from K031495

207 later devices reach Pinnacle Duofix HA Acetabular Cup Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K211866Bencox THR SystemCorentec Co., Ltd.20210—
+5K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K210062Mectaplug PE IIMedacta International S.A.20210—
+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—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+5K162035GMK SphereMedacta International S.A.201710—
+5K140826GMK Sphere ExtensionMedacta International201417—
+5K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+5K133630GMK Short StemMedacta International20131—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+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—
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K241461Mpact Constrained LinerMedacta International S.A.20251—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K230011Mpact ExtensionMedacta International S.A.20233—
+6K231037MyKnee UNI-STMedacta International S.A.20230—
+6K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K200391MPACT ExtensionMedacta International S.A.20210—
+6K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K193559NextAR TKA PlatformMedacta Inernational SA202012—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K183582MPACT ExtensionMedacta International S.A.20194—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+6K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+6K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+6K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K171156OMNI Anseris Hip StemOmnilife Science20170—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K143453Mpact Double Mobility SystemMedacta International20151—
+6K132879Mpact ExtensionMedacta International201411—
+6K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+6K131458Mpact DM Liner ConverterMedacta International20133—
+6K122911Versafitcup CC Trio ExtensionMedacta International20121—
+6K122641Mpact ExtensionMedacta International201214—
+6K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+6K111145Endo HeadMedacta International20110—
+7K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+7K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K252847NextAR Hip PlatformMedacta International S.A.20260—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+7K251166Mfinity Femoral SystemMedacta International S.A.20250—
+7K251052Trivicta® Hip StemOrtho Development Corp.20250—
+7K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+7K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+7K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+7K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+7K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+7K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+7K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+7K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+7K211891DM Converter - TiN coatedMedacta International S.A.20220—
+7K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+7K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+7K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+7K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+7K211703Insignia Hip StemStryker Orthopaedics20217—
+7K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+7K210153NextAR RSA PlatformMedacta International S.A.202151
+7K202152NextAR TKA PlatformMedacta International S.A.202011—
+7K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+7K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+7K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+8K250477NextAR (TM) SpineMedacta International S.A.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+8K220731Insignia Hip Stem, Restoration Modular 115mm Conical Distal StemStryker20226—
+8K221104Actera™ hip systemConformis, Inc.202211