510(k) Report

Devices descending from K030259

331 later devices reach Amatomical Shoulder with Removable Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+3K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K131129Cas Psi ShoulderZimmer Cas201339—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K131112Limacorporate SMR Cta Humeral HeadsLima Corporate S.P.A.20130—
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+3K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+3K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+3K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+3K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+3K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+3K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+3K111902Aequalis Shoulder SystemTornier201149—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+3K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+3K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+3K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+3K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+3K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+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—
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+4K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+4K241043Augment Off-Axis Instrument SystemFix Surgical202415
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+4K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+4K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+4K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+4K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+4K193175Lateralized GlenosphereMedacta Inernational SA20201—
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+4K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+4K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+4K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+4K170452Medacta Shoulder SystemMedacta International S.A.201712—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+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—
+4K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K141345Aequalis FX2Tornier S.A.S.201411
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+4K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K113413Ascend Shoulder SystemTornier, Inc.2012105—