510(k) Report

Devices descending from K984541

425 later devices reach Global FX Humeral Stem, Global Advantage Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+4K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+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—
+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—
+4K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K121493Ascend Shoulder SystemTornier, Inc.201297—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+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—
+4K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+4K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+4K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+4K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+4K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+4K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+4K071948Aequalis Reversed AdapterTornier2007178—
+4K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+4K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+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—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20220—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+5K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K192967Medacta Shoulder SystemMedacta International S.A.20200—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+5K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+5K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+5K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+5K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+5K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+5K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—