510(k) Report

Devices descending from K041066

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+3K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K241043Augment Off-Axis Instrument SystemFix Surgical202415
+3K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+3K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+3K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+3K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+3K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+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—
+3K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+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—
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K192967Medacta Shoulder SystemMedacta International S.A.20200—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K193099Anatomical Shoulder SystemZimmer GmbH20201—
+3K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+3K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+3K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+3K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+3K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K163669Humeris ShoulderFx Solutions201720—
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+3K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+3K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+3K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+3K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+3K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+3K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+3K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+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—