510(k) Report

Devices descending from K974044

440 later devices reach Global Total Shoulder Eccentric Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K193175Lateralized GlenosphereMedacta Inernational SA20201—
+4K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+4K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+4K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+4K163669Humeris ShoulderFx Solutions201720—
+4K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+4K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+4K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+4K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K143552Simpliciti Shoulder SystemTornier, Inc.201524—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+4K141345Aequalis FX2Tornier S.A.S.201411
+4K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+4K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+4K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+4K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+4K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+4K131129Cas Psi ShoulderZimmer Cas201339—
+4K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+4K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+4K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+4K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+4K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+4K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+4K122442Depuy Cta Reverse Shoulder SystemDepuy France20121—
+4K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+4K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K121493Ascend Shoulder SystemTornier, Inc.201297—
+4K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+4K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+4K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+4K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+4K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+4K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+4K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+4K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+4K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+4K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+4K071948Aequalis Reversed AdapterTornier2007178—
+4K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+4K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K250848Identity Shoulder SystemZimmer, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20220—