510(k) Report

Devices descending from K955731

242 later devices reach Osteonics Shoulder Humeral Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+5K170452Medacta Shoulder SystemMedacta International S.A.201712—
+5K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+5K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+5K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+5K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+5K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+5K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+5K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+5K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+5K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+5K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+5K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+5K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+5K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+5K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+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
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+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—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+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—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+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—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+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—
+6K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+6K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+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—
+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