510(k) Report

Devices descending from K962315

335 later devices reach Select Shoulder Cocr Humeral Stem Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041339Aequalis Shoulder SystemTornier2004259—
+1K982981New Zimmer Shoulder SystemZimmer, Inc.19982351
+2K171858Sidus Stem-Free ShoulderZimmer GmbH2017133
+2K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+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—
+2K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+2K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+2K062661Aequalis Resurfacing HeadTornier200616—
+2K061439Aequalis Reversed ProsthesisTornier2006199—
+2K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006257—
+2K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004258—
+2K041549Zimmer Trabecular Metal Humeral StemZimmer, Inc.20042188
+2K030344Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral HeadsSmith & Nephew, Inc.20030—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, 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—
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+3K183194Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20198—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K170452Medacta Shoulder SystemMedacta International S.A.201712—
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+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—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K111902Aequalis Shoulder SystemTornier201149—
+3K110905Total Shoulder SystemShoulder Innovations, LLC20110—
+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
+3K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+3K071948Aequalis Reversed AdapterTornier2007178—
+3K063081Aequalis Shoulder SystemTornier2006162—
+3K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+3K050761Zimmer Trabecular Metal Humeral Stem, Sizes 6MM and 8MMZimmer, Inc.200506
+4K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+4K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+4K250644MSS - Monobloc stemMedacta International S.A.202611
+4K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+4K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+4K221758SMR Stemless AnatomicLima Corporate S.P.A.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+4K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+4K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+4K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K201391Easytech® Anatomical Shoulder SystemFx Shoulder USA, Inc.20210—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+4K201542Arthrex Eclipse Shoulder Prosthesis SystemArthrex, Inc.20201—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+4K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+4K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+4K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+4K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+4K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+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
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—