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
+4K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+4K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K142388Neo Total Knee SystemNew Era Orthopedics, LLC20140—
+4K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics20142811
+4K132879Mpact ExtensionMedacta International201411—
+4K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics2013381
+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—
+4K081293Univation Unicondylar Knee SystemAesculap Implant Systems, Inc.200818
+4K071499Columbus Total Knee System Mios CR/PS Tibial TrayAesculap Implant Systems, Inc.20076—
+4K053579Columbus Ultra Congruent (UC) Tibial Insert/Gliding SurfaceAesculap, Inc.20060—
+4K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+4K033260AequosAap Implantate AG200419—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.20260—
+5K252847NextAR Hip PlatformMedacta International S.A.20260—
+5K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20252—
+5K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.20250—
+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—
+5K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.20253—
+5K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.20241—
+5K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+5K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics20243—
+5K240393Exactech® TRULIANT® Knee SystemExactech, Inc.20240—
+5K240938The Optimotion™ Blue Plus Knee SystemOptimotion Implants, LLC20240—
+5K240678ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC20240—
+5K232303ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized…Depuy Ireland UC202311
+5K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+5K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics20234—
+5K230416Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®Stryker20233—
+5K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics202341
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+5K220049Optimotion Implants Porous Metal-Backed PatellaOptimotion Implants, LLC20220—
+5K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+5K212941Porous PatellaEncore Medical, L.P. Dba Djo Surgical202211
+5K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+5K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+5K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+5K210153NextAR RSA PlatformMedacta International S.A.202151
+5K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+5K202152NextAR TKA PlatformMedacta International S.A.202011—
+5K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+5K193414Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20206—
+5K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20197—
+5K190991Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal AugmentHowmedica Osteonics Corp. (Aka Stryker Orthopaedics)201904
+5K181061Corin Optimized Positioning System (OPS) FemoralCorin USA20181—
+5K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20183—
+5K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+5K161668ConforMIS iTotal (R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)Conformis, Inc.2016174
+5K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+5K141934Physica KR Knee SystemLima Corporate S.P.A.201518—
+5K131167UnivationAesculap Implant Systems, LLC201308
+6K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.20250—
+6K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.20250—
+6K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+6K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—
+6K250477NextAR (TM) SpineMedacta International S.A.20250—
+6K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+6K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+6K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+6K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+6K152008Physica PS Knee SystemLima Corporate S.P.A.20157—
+6K151266Physica CR Knee SystemLima Corporate S.P.A.20158—
+7K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+7K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+7K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+7K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+7K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+7K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+7K203421Triathlon AS-1Conformis, Inc.20210—
+7K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+8K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+8K223876SMR Shoulder SystemLima Corporate S.P.A.20233—