510(k) Report

Devices descending from K990137

365 later devices reach Anatomica Humeral Stem/Head Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+4K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+4K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+4K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+4K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+4K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+4K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+4K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+4K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+4K150730Zimmer PSI Shoulder SystemZimmer201511—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+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—
+4K142413TITAN Modular Total Shoulder SystemAscension Orthopedics20142—
+4K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+4K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+4K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+4K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K131112Limacorporate SMR Cta Humeral HeadsLima Corporate S.P.A.20130—
+4K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+4K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+4K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+4K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+4K113413Ascend Shoulder SystemTornier, Inc.2012105—
+4K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+4K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+4K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+4K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+4K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+4K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+4K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+4K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+4K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+5K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—