510(k) Report

Devices descending from K992065

405 later devices reach Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+3K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+3K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+3K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K163669Humeris ShoulderFx Solutions201720—
+3K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+3K152966Aequalis Fx2Tornier S.A.S.201601
+3K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+3K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+3K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K143552Simpliciti Shoulder SystemTornier, Inc.201524—
+3K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+3K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+3K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+3K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+3K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+3K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+3K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+3K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K131129Cas Psi ShoulderZimmer Cas201339—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+3K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+3K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+3K122442Depuy Cta Reverse Shoulder SystemDepuy France20121—
+3K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K112983Spacer-STecres S.P.A.20117—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+3K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+3K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+3K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+3K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+3K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+3K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+3K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+3K071948Aequalis Reversed AdapterTornier2007178—
+3K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+3K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+3K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K243448Equinoxe® Shoulder SystemExactech, Inc.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—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+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—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+4K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+4K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+4K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+4K213615Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20220—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—