510(k) Report

Devices descending from K051075

248 later devices reach Encore Reverse Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K201315PERFORM Humeral System – StemTornier, Inc.2020111
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K193099Anatomical Shoulder SystemZimmer GmbH20201—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K172054Materialise Glenoid Positioning SystemMaterialise NV20170—
+3K170893Materialise Glenoid Positioning SystemMaterialise NV201711
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+3K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+3K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K260556Veritas Shoulder SystemRestor3D20260—
+4K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K243509Archer PSI System3D-Side20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+4K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+4K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K163669Humeris ShoulderFx Solutions201720—
+4K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+4K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—