510(k) Report

Devices descending from K063569

190 later devices reach Equinoxe Reverse Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+1K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+1K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+1K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+1K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+1K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+1K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+1K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+1K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+1K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+1K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+1K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+1K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+1K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+1K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+1K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+2K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+2K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+2K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+2K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+2K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+2K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+2K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+2K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+2K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+2K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+2K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+2K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+2K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+2K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+2K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+2K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+2K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+2K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+2K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+3K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+3K241043Augment Off-Axis Instrument SystemFix Surgical202415
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+3K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K193099Anatomical Shoulder SystemZimmer GmbH20201—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K260556Veritas Shoulder SystemRestor3D20260—
+4K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+4K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—