510(k) Report

Devices descending from K003801

365 later devices reach Anatomical Press-Fit Humeral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+5K193175Lateralized GlenosphereMedacta Inernational SA20201—
+5K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+5K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+5K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+5K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+5K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+5K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+5K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+5K170452Medacta Shoulder SystemMedacta International S.A.201712—
+5K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+5K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+5K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+5K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+5K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+5K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+5K150730Zimmer PSI Shoulder SystemZimmer201511—
+5K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+5K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+5K141345Aequalis FX2Tornier S.A.S.201411
+5K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+5K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+5K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+5K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+5K113413Ascend Shoulder SystemTornier, Inc.2012105—
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+5K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+5K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+6K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+6K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+6K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+6K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+6K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+6K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+6K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+6K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+6K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+6K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+6K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+6K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+6K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+6K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+6K152966Aequalis Fx2Tornier S.A.S.201601
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+6K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+6K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+6K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+6K141006RSP Humeral Socket InsertDjo Global2014212
+6K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+6K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+6K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+6K120794Ascend Shoulder SystemTornier, Inc.201298—
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—