510(k) Report

Devices descending from K895226

236 later devices reach Neer II Total Shoulder System & Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+5K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+5K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+5K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+5K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+5K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+5K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+5K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+6K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+6K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K193175Lateralized GlenosphereMedacta Inernational SA20201—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+6K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+6K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+6K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+6K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+6K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+6K141345Aequalis FX2Tornier S.A.S.201411
+6K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+6K141006RSP Humeral Socket InsertDjo Global2014212
+6K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+6K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+6K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+6K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+6K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+6K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+6K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+6K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+6K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+6K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+7K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+7K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+7K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+7K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+7K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+7K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+7K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+7K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+7K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+7K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+7K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+7K152966Aequalis Fx2Tornier S.A.S.201601
+7K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+7K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+7K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+7K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+7K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+7K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+8K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+8K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+8K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+8K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+8K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+8K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+8K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+8K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+8K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+8K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+8K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+8K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+8K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+8K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+8K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+8K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+8K163669Humeris ShoulderFx Solutions201720—