510(k) Report

Devices descending from K992119

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+3K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+3K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+3K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+3K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+3K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+3K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+3K152966Aequalis Fx2Tornier S.A.S.201601
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+3K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.20141—
+3K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+3K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+3K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+3K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+3K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+3K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+3K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+3K131633Arthrex Univers ApexArthrex, Inc.20134—
+3K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+3K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+3K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+3K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+3K122442Depuy Cta Reverse Shoulder SystemDepuy France20121—
+3K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+3K120794Ascend Shoulder SystemTornier, Inc.201298—
+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
+3K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+3K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+3K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+3K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+3K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+3K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+3K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+3K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+3K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+3K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+3K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+3K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+3K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+3K071948Aequalis Reversed AdapterTornier2007178—
+3K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621
+3K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+3K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+3K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+3K033516Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc.2003135—