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
+1K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+1K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+1K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+1K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+1K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+1K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc.20021462
+1K011099Global FX Porous-Coated Humeral StemDePuy Orthopaedics, Inc.200175—
+1K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadDePuy Orthopaedics, Inc.1999405—
+2K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+2K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+2K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+2K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+2K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+2K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+2K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+2K133834Depuy Global Unite Shoulder SystemDepuy (Ireland)2014211
+2K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+2K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+2K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+2K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+2K111097Humelock Cemented Shoulder ProsthesisFx Solutions2011342
+2K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+2K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+2K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+2K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+2K070565Cofield Total Shoulder SystemSmith & Nephew, Inc.200726—
+2K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+2K060988Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC200619413
+2K060874Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc.2006200—
+2K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+2K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+2K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+2K042664LPS Upper ExtremityDepuy, Inc.20040—
+2K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+2K033506Comprehensive Humeral Fracture Positioning SleeveBiomet, Inc.20041—
+2K021478Delta ShoulderDepuy, Inc.2003338—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+3K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+3K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K193099Anatomical Shoulder SystemZimmer GmbH20201—
+3K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K170452Medacta Shoulder SystemMedacta International S.A.201712—
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+3K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+3K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+3K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K131633Arthrex Univers ApexArthrex, Inc.20134—
+3K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+3K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412