510(k) Report

Devices descending from K923277

238 later devices reach Foundation Knee System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161366ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)Conformis, Inc.201618—
+4K143647Renovis Surgical Hip Replacement SystemRenovis Surgical Technologies, Inc.20151—
+4K142069GMK ExtensionMedacta International20144—
+4K140130X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…Encore Medical L.P.20141—
+4K141676Renovis Surgical Porous Acetabular Cup SystemRenovis Surgical Technologies, Inc.20144—
+4K140826GMK Sphere ExtensionMedacta International201417—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K133560Itotal Cruciate Retaining Knee Replacment SystemConformis, Inc.20140—
+4K133630GMK Short StemMedacta International20131—
+4K131310GMK Full PE Tibial ComponentsMedacta International20132—
+4K123721GMK Revision ExtensionMedacta International20133—
+4K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.201330—
+4K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.201330—
+4K123692Pipeline Knee SystemPipeline Orthopedics20130—
+4K122232GMK NarrowMedacta International20128—
+4K121416GMK SphereMedacta International201220—
+4K120790GMK - Line ExtensionMedacta International201211—
+4K113571GMK Resufacing Patella Size 4Medacta International201223—
+4K111283GMK Revision Hybrid LinersMedacta International20110—
+4K103170GMK Revision Knee SC LinersMedacta International S.A.201128—
+4K102437GMK Revision Knee SystemMedacta International S.A.201034—
+4K093806Myknee Cutting BlocksMedacta International S.A.201016—
+4K053390Columbus (CR) Total Knee SystemAesculap, Inc.200651
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.20260—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.20250—
+5K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K250677LEGION Total Knee SystemSmith & Nephew, Inc.20250—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K223252TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX PatellasExactech, Inc.202301
+5K231037MyKnee UNI-STMedacta International S.A.20230—
+5K223548GMK Sphere & GMK SpheriKA CementlessMedacta International S.A.20231—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K212411Identity Imprint Knee Replacement System (including Identity Imprint Posterior…Conformis, Inc.20219—
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K211004GMK Spherika Femurs and Fixed Tibial Trays PlusMedacta International S.A.20214—
+5K210191Identity Imprint Knee Replacement SystemConformis, Inc.2021101
+5K210062Mectaplug PE IIMedacta International S.A.20210—
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc.202012—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K201660KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…Kyocera Medical Technologies, Inc.20200—
+5K193559NextAR TKA PlatformMedacta Inernational SA202012—
+5K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K181635GMK Sphere CR Tibial InsertsMedacta International S.A.20182—
+5K180906Conformis iTotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2018174
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+5K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+5K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+5K162035GMK SphereMedacta International S.A.201710—
+5K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+5K143443VEGA Knee System, Columbus Total Knee SystemAesculap Implants Systems, LLC20153—
+5K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+5K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+5K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+5K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+5K120955Columbus Total Knee System as Columbus Revision Knee System Enduro Knee SystemAesculap Implant Systems, LLC20124—
+6K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+6K252847NextAR Hip PlatformMedacta International S.A.20260—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+6K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+6K213389Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint…Conformis, Inc.20218—
+6K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+6K210153NextAR RSA PlatformMedacta International S.A.202151
+6K210809iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)Conformis, Inc.202141
+6K203421Triathlon AS-1Conformis, Inc.20210—
+6K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+6K202152NextAR TKA PlatformMedacta International S.A.202011—
+6K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+6K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—