510(k) Report

Devices descending from K062116

295 later devices reach Delta Cta Reverse Shoulder System Humeral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+4K241043Augment Off-Axis Instrument SystemFix Surgical202415
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+4K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+4K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+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—
+4K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+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—
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+4K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+4K150730Zimmer PSI Shoulder SystemZimmer201511—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+4K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+5K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+5K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+5K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K193523ArthrexVIP Web PortalArthrex, Inc.20200—