510(k) Report

Devices descending from K021478

338 later devices reach Delta Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+1K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+1K103251Duocentric ReversedAston Medical20117—
+1K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+1K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+1K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+1K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+1K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+1K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+1K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295—
+1K061439Aequalis Reversed ProsthesisTornier2006199—
+1K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+1K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+1K050315Delta Humeral CupsDePuy Orthopaedics, Inc.2005196—
+1K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+1K041873Aequalis Reversed Shoulder ProsthesisTornier2004277—
+1K030941Aequalis Reversed Shoulder ProsthesisTornier2004280—
+2K254003JARVIS Metaphyseal StemFH Industrie20260—
+2K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+2K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+2K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+2K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+2K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+2K193175Lateralized GlenosphereMedacta Inernational SA20201—
+2K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+2K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+2K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+2K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+2K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+2K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+2K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+2K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+2K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+2K162455Humelock Reversed ShoulderFx Solutions201717—
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K152966Aequalis Fx2Tornier S.A.S.201601
+2K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+2K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+2K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+2K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+2K141345Aequalis FX2Tornier S.A.S.201411
+2K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+2K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+2K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+2K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+2K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+2K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+2K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+2K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+2K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+2K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+2K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+2K122442Depuy Cta Reverse Shoulder SystemDepuy France20121—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+2K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+2K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+2K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+2K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+2K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+2K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+2K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+2K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+2K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+2K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+2K071948Aequalis Reversed AdapterTornier2007178—
+2K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+2K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—