510(k) Report

Devices descending from K030710

253 later devices reach Bio-Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+3K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+3K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+3K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K121493Ascend Shoulder SystemTornier, Inc.201297—
+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—
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+3K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+3K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K250848Identity Shoulder SystemZimmer, Inc.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241043Augment Off-Axis Instrument SystemFix Surgical202415
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+4K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K141345Aequalis FX2Tornier S.A.S.201411
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+5K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—