510(k) Report

Devices descending from K031061

193 later devices reach Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240299Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)Zimmer, Inc.20243—
+4K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+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—
+4K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+4K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+4K230321Persona™ Personalized Knee SystemZimmer, Inc.20230—
+4K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+4K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLC20220—
+4K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical202211
+4K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+4K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+4K193559NextAR TKA PlatformMedacta Inernational SA202012—
+4K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+4K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+4K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+4K193284Physica LMC Knee SystemLima Corporate S.P.A.20206—
+4K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+4K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+4K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+4K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+4K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+4K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K132879Mpact ExtensionMedacta International201411—
+4K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K111145Endo HeadMedacta International20110—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+5K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+5K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+5K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+5K230078TRAX® CR Total Knee SystemAmplitude20230—
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+5K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+5K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+5K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+5K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+5K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K202152NextAR TKA PlatformMedacta International S.A.202011—
+5K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+5K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+6K250477NextAR (TM) SpineMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K233172NextAR™ Spine PlatformMedacta International S.A.20241—