510(k) Report

Devices descending from K911686

436 later devices reach Global Total Shoulder, Uncement Humeral Hemi-Shoul through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc.2003141—
+1K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadDePuy Orthopaedics, Inc.1999405—
+1K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999425—
+2K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+2K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+2K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+2K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+2K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemArthrosurface, Inc.20141—
+2K133834Depuy Global Unite Shoulder SystemDepuy (Ireland)2014211
+2K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+2K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+2K112900SMR Resurfacing Shoulder System- Humeral Heads, Cta Humeral HeadsLima Corporate S.P.A.20120—
+2K111097Humelock Cemented Shoulder ProsthesisFx Solutions2011342
+2K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+2K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+2K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+2K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082—
+2K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+2K071064Ascension Humeral Resurfacing Arthoplasty (Hra) System TPS/HAAscension Orthopedics, Inc.20070—
+2K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+2K060988Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC200619413
+2K062861Ascension Humeral Resurfacing Arthroplasty SystemAscension Orthopedics, Inc.200621
+2K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+2K060874Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc.2006200—
+2K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.200561
+2K042664LPS Upper ExtremityDepuy, Inc.20040—
+2K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+2K033516Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc.2003135—
+2K021478Delta ShoulderDepuy, Inc.2003338—
+2K023063Comprehensive Humeral Fracture SystemBiomet Orthopedics, Inc.20021462
+2K011099Global FX Porous-Coated Humeral StemDePuy Orthopaedics, Inc.200175—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+3K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+3K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+3K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+3K170452Medacta Shoulder SystemMedacta International S.A.201712—
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+3K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+3K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+3K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+3K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+3K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+3K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+3K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+3K123814Humelock II Cemented Shoulder SystemFx Solutions201332—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+3K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+3K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+3K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+3K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K111902Aequalis Shoulder SystemTornier201149—
+3K103251Duocentric ReversedAston Medical20117—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+3K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+3K103007Affiniti Total and Hemi-Shoulder SystemTornier, Inc.201071—
+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
+3K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+3K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+3K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+3K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+3K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+3K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC20083—
+3K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+3K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+3K070565Cofield Total Shoulder SystemSmith & Nephew, Inc.200726—
+3K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+3K063652Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc.200718—
+3K062661Aequalis Resurfacing HeadTornier200616—
+3K063081Aequalis Shoulder SystemTornier2006162—