510(k) Report

Devices descending from K050222

255 later devices reach Vanguard Anterior Stabilized Tibial Bearings through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+4K141635Arthrex Ibalance Tka SystemArthrex, Inc.201415—
+4K140830Exprt Revision KneeEncore Medical L.P.201471
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.201426—
+4K140701Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugNovosource, Inc.20142—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140423Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2014251
+4K132312Renovis Tesera Trabecular Technology (T3) Acetabular Shell SystemRenovis Surgical Technologies, LLC20146—
+4K133256Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo…Conformis, Inc.2014166
+4K123459Zimmer Persona TM Personalized Knee SystemZimmer, Inc.2013910
+4K111981Tregor Dual Mobility Acetabular SystemAston Medical20120—
+4K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120—
+4K110555Arcomxl Active ArticulationBiomet Manufacturing Corp2011222
+5K261453G7® Acetabular SystemZimmer Biomet20260—
+5K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+5K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+5K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+5K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.20250—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+5K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P.20250—
+5K251834Persona Partial KneeZimmer Biomet20250—
+5K243456ONVOY™ Acetabular SystemGlobus Medical, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K250834Zimmer Biomet Ceramic Heads (22.2mm diameter)Zimmer Biomet20250—
+5K242045Initia T3 Acetabular Hemispherical Shell SystemKyocera Medical Technologies, Inc.20250—
+5K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+5K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+5K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC20240—
+5K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+5K241570Unity Total Knee SystemCorin U.S.A. Limited20240—
+5K23372428mm/38D MDM X3 Insert for MDM LinerHowmedica Osteonics Corp., Dba Stryker Orthopaedics20240—
+5K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate…Conformis, Inc.20232—
+5K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K212870TLC Unicompartmental Knee SystemSignature Orthopaedics Pty, Ltd.20222—
+5K213793EMPOWR Revision KneeEncore Medical L.P.20221—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSMicroport Orthopedics, Inc.20211—
+5K211609ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) InsertDepuy Ireland UC20212—
+5K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG202111
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K203421Triathlon AS-1Conformis, Inc.20210—
+5K203472KMTI Hip Replacement SystemKyocera Medical Technologies, Inc.20210—
+5K210308EMPOWR Porous Femur with HAnano SurfaceTMEncore Medical L.P.20210—
+5K210551Persona Revision Knee SystemZimmer, Inc.202101
+5K203557EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly BearingEncore Medical L.P.202102
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+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—
+5K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K200151Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial…Zimmer, Inc.20200—
+5K193105iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System…Conformis, Inc.202015—
+5K200328Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemKyocera Medical Technologies, Inc.20201—
+5K193223Persona Personalized Knee SystemZimmer, Inc.20203—
+5K190562iTotal Identity Cruciate Retaining Knee Replacement SystemConformis, Inc.201915—
+5K191211JOURNEY II Unicompartmental Knee SystemSmith & Nephew, Inc.20191—
+5K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K190085Journey II Unicompartmental Knee SystemSmith & Nephew, Inc.201973
+5K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+5K181366REDAPT Porous Acetabular ShellSmith & Nephew, Inc.20181—
+5K173890GMK Sphere - Kinematic AlignmentMedacta International S.A.20186—
+5K180930Empowr VVC Tibial InsertEncore Medical L.P.201831
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K170359Trinity™ Dual Mobility SystemCorin U.S.A. Limited2017101
+5K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+5K161945EXPRT Revision Knee Femoral Augment (5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.20160—
+5K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC20161—
+5K151256Arthrex BioSync® Bone WedgeArthex, Inc.2015106
+5K142404iTotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014242
+5K142161Itotal Cruciate Retaining (CR) Knee Replacement System, Itotal Posterior Stabilized (PS)…Conformis, Inc.2014246
+6K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+6K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+6K261609Freedom Partial Knee SystemMaxx Orthopedics, Inc.20260—
+6K251771Cambridge Partial KneeSignature Orthopaedics Pty, Ltd.20250—
+6K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC20250—
+6K242744Trinity EVO Acetabular ShellCorin U.S.A. Limited20250—
+6K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.20250—
+6K240461OsteoSinter® EVANS and COTTON wedges and related accessoriesAmes Medical Prosthetic Solutions, S.A.U.20242—
+6K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+6K232114TRIBRID® Unicompartmental Knee SystemKyocera Medical Technologies, Inc.20240—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K230078TRAX® CR Total Knee SystemAmplitude20230—
+6K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with…Conformis, Inc.20230—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K222066LINK MobileLink Acetabular Cup SystemWaldemar Link GmbH & Co. KG20230—
+6K230169EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial InsertEncore Medical, L.P Dba Enovis20232—
+6K230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating SurfaceWaldemar Link GmbH & Co. KG20230—
+6K230441EMPOWR Stem Extender, 50mmEncore Medical, L.P Dba Enovis20230—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+6K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.20220—
+6K221850GMK 3D Metal Tibial TrayMedacta International S.A.20221—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—