510(k) Report

Devices descending from K051075

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+1K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+1K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+1K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+1K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+1K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+1K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+1K141006RSP Humeral Socket InsertDjo Global2014212
+1K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+1K131559Match Point System (TM), Surgicase Connect, Match Point System (TM) GuidesMaterialise NV201335—
+1K112069RSP Glenoid Baseplate Porous CoatedEncore Medical L.P.2011741
+1K111061Reverse Shoulder Monoblock Prosthesis (RSP)Encore Medical L.P.201119—
+1K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+1K100741Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts…Encore Medical L.P.2010651
+1K092873Reverse Shoulder ProsthesisDjo Surgical2009125—
+1K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+1K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+1K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+1K052086Encore Reverse Shoulder Prosthesis Humeral Stem AdapterEncore Medical, Inc.2005201—
+2K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+2K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+2K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+2K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+2K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+2K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+2K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+2K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+2K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+2K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+2K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+2K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+2K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+2K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+2K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+2K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+2K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+2K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+2K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+2K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+2K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K153602Materialise Glenoid Positioning SystemMaterialise NV201621
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+2K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+2K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+2K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+2K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+2K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+2K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+2K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+2K111735Reverse Shoulder Prosthesis Monoblock Hemi AdapterEncore Medical L.P.201160—
+2K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+2K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+2K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+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—
+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—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222