510(k) Report

Devices descending from K911686

436 later devices reach Global Total Shoulder, Uncement Humeral Hemi-Shoul through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc.2006121—
+3K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295—
+3K061439Aequalis Reversed ProsthesisTornier2006199—
+3K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+3K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+3K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+3K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+3K050315Delta Humeral CupsDePuy Orthopaedics, Inc.2005196—
+3K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+3K041873Aequalis Reversed Shoulder ProsthesisTornier2004277—
+3K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+3K030941Aequalis Reversed Shoulder ProsthesisTornier2004280—
+3K033506Comprehensive Humeral Fracture Positioning SleeveBiomet, Inc.20041—
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+4K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241470CORE Shoulder SystemLinkBio Corp.202501
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+4K193175Lateralized GlenosphereMedacta Inernational SA20201—
+4K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+4K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+4K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+4K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+4K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+4K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+4K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+4K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+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—
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K163669Humeris ShoulderFx Solutions201720—
+4K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+4K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+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—
+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
+4K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+4K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+4K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+4K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+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—
+4K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+4K131633Arthrex Univers ApexArthrex, Inc.20134—
+4K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+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—
+4K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+4K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+4K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—