510(k) Report

Devices descending from K043100

176 later devices reach Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+3K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+3K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+3K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+3K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+3K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+3K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+3K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+3K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K241043Augment Off-Axis Instrument SystemFix Surgical202415
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+4K141345Aequalis FX2Tornier S.A.S.201411
+4K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+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—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+5K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K152966Aequalis Fx2Tornier S.A.S.201601
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K143256SMR Modular GlenoidLima Corporate S.P.A.20150—