510(k) Report

Devices descending from K002683

288 later devices reach WMT Ultra-Fit Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004258—
+1K032679Aequalis Shoulder Fracture SystemTornier2003287—
+2K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+2K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+2K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+2K062661Aequalis Resurfacing HeadTornier200616—
+2K063081Aequalis Shoulder SystemTornier2006162—
+2K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006257—
+2K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+3K170452Medacta Shoulder SystemMedacta International S.A.201712—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+3K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+3K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+3K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+3K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+3K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K111902Aequalis Shoulder SystemTornier201149—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+3K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+3K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+3K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+3K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+3K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+3K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+3K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+3K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+3K061439Aequalis Reversed ProsthesisTornier2006199—
+3K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+3K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+4K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+4K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+4K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+4K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+4K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+4K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+4K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+4K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+4K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+4K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+4K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+4K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+4K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+4K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+4K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+4K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—