510(k) Report

Devices descending from K023211

293 later devices reach Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K213781ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DPDepuy Ireland UC202201
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc.20215—
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K201611Apex Knee SystemOmnilife Science20210—
+5K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics20201—
+5K193559NextAR TKA PlatformMedacta Inernational SA202012—
+5K200782Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon…Howmedica Osteonics Corp.20200—
+5K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd.20202—
+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
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+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—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K173849Triathlon Total Knee SystemStryker Orthopaedics2018143
+5K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+5K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+5K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+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—
+5K143453Mpact Double Mobility SystemMedacta International20151—
+5K132879Mpact ExtensionMedacta International201411—
+5K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131458Mpact DM Liner ConverterMedacta International20133—
+5K130084Milestone Revision Knee System (MRKS) - Femoral Component, Tibial Baseplate, Tibial…Tgm Medical, Inc.20130—
+5K122911Versafitcup CC Trio ExtensionMedacta International20121—
+5K122641Mpact ExtensionMedacta International201214—
+5K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+5K111145Endo HeadMedacta International20110—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K252847NextAR Hip PlatformMedacta International S.A.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—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.20251—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+6K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+6K243231Trigon PEEK HA WedgesNvision Biomedical Technologies20241—
+6K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemGlobus Medical, Inc.20241—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies20240—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K223226Trigon™ HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20220—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K211891DM Converter - TiN coatedMedacta International S.A.20220—
+6K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp.20220—
+6K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+6K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+6K220197Trigon HA Wedge Fixation SystemNvision Biomedical Technologies, Inc.20224—
+6K212034LOSPA TKR SystemCorentec Co., Ltd.20210—
+6K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+6K210153NextAR RSA PlatformMedacta International S.A.202151
+6K203445Trigon HA Stand-Alone Wedge Fixation SystemNvision Biomedical Technologies, Inc.20205—
+6K202152NextAR TKA PlatformMedacta International S.A.202011—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K201851EXULT Femoral component trial - Left, EXULT Femoral component trial - RightCorentec Co., Ltd.20200—
+6K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+6K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+6K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+6K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+7K250477NextAR (TM) SpineMedacta International S.A.20250—
+7K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+7K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+7K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+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—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+8K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+8K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+8K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+8K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+9K230846iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement SystemConformis, Inc.20232—
+9K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate…Conformis, Inc.20231—
+9K221059Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20227—
+10K221404Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20226—
+11K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRSConformis, Inc.202301