510(k) Report

Devices descending from K802123

415 later devices reach Monospherical Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991585Bipolar Shoulder ProsthesisBiomet, Inc.1999414—
+2K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+2K041873Aequalis Reversed Shoulder ProsthesisTornier2004277—
+2K030941Aequalis Reversed Shoulder ProsthesisTornier2004280—
+2K021478Delta ShoulderDepuy, Inc.2003338—
+2K010827Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc.20011421
+2K010657Copeland MB Resurfacing Humeral HeadsBiomet Manufacturing, Inc.2001136—
+2K002998Biomet BI-Polar Shoulder SystemBiomet, Inc.20002651
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K152966Aequalis Fx2Tornier S.A.S.201601
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+3K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+3K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+3K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+3K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+3K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+3K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+3K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+3K103251Duocentric ReversedAston Medical20117—
+3K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+3K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+3K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+3K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+3K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+3K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+3K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+3K071948Aequalis Reversed AdapterTornier2007178—
+3K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+3K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+3K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+3K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+3K062661Aequalis Resurfacing HeadTornier200616—
+3K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc.2006121—
+3K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295—
+3K061439Aequalis Reversed ProsthesisTornier2006199—
+3K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+3K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+3K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.200561
+3K050315Delta Humeral CupsDePuy Orthopaedics, Inc.2005196—
+3K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc.2003141—
+3K030710Bio-Modular Shoulder SystemBiomet, Inc.20032531
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+4K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+4K193175Lateralized GlenosphereMedacta Inernational SA20201—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+4K191814Alliance GlenoidZimmer, Inc.20194—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+4K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+4K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+4K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+4K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K170452Medacta Shoulder SystemMedacta International S.A.201712—
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+4K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+4K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+4K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+4K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+4K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+4K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+4K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+4K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.20141—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K141345Aequalis FX2Tornier S.A.S.201411
+4K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+4K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—