510(k) Report

Devices descending from K920362

353 later devices reach 3M Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K002683WMT Ultra-Fit Modular Shoulder SystemWrightmedicaltechnologyinc2000288—
+1K982981New Zimmer Shoulder SystemZimmer, Inc.19982351
+2K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+2K110791Bigliani / Flatow (R) the Complete Shoulder SolutionZimmer, Inc.201101
+2K111596Total Shoulder SystemShoulder Innovations, LLC201115—
+2K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+2K102670Total Shoulder SystemShoulder Innovations, LLC201118—
+2K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004258—
+2K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc.20042188
+2K032679Aequalis Shoulder Fracture SystemTornier2003287—
+2K030344Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral HeadsSmith & Nephew, Inc.20030—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+3K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+3K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+3K110905Total Shoulder SystemShoulder Innovations, LLC20110—
+3K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+3K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+3K062661Aequalis Resurfacing HeadTornier200616—
+3K063081Aequalis Shoulder SystemTornier2006162—
+3K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006257—
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+3K050761Zimmer Trabecular Metal Humeral Stem, Sizes 6MM and 8MMZimmer, Inc.200506
+3K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+4K193175Lateralized GlenosphereMedacta Inernational SA20201—
+4K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K170452Medacta Shoulder SystemMedacta International S.A.201712—
+4K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+4K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+4K141345Aequalis FX2Tornier S.A.S.201411
+4K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+4K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+4K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+4K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+4K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+4K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+4K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+4K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+4K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+4K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+4K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+4K111902Aequalis Shoulder SystemTornier201149—
+4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+4K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+4K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+4K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+4K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+4K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+4K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+4K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+4K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+4K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+4K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+4K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+4K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+4K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+4K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+4K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+4K061439Aequalis Reversed ProsthesisTornier2006199—
+4K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+4K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+4K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+5K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+5K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+5K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—