510(k) Report

Devices descending from K915596

254 later devices reach Biomodular Shoulder Humeral Head W/ Ionguard through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+4K193175Lateralized GlenosphereMedacta Inernational SA20201—
+4K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+4K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+4K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K121493Ascend Shoulder SystemTornier, Inc.201297—
+4K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+4K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+4K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+4K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+4K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+4K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+4K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K250848Identity Shoulder SystemZimmer, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+5K202338SpaceFlex ShoulderG21, S.R.L.20211—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+5K193099Anatomical Shoulder SystemZimmer GmbH20201—
+5K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K141345Aequalis FX2Tornier S.A.S.201411
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+5K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+5K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+6K260556Veritas Shoulder SystemRestor3D20260—
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—