510(k) Report

Devices descending from K121493

97 later devices reach Ascend Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+2K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+2K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+2K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+2K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+2K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+2K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+2K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+2K163669Humeris ShoulderFx Solutions201720—
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+2K141345Aequalis FX2Tornier S.A.S.201411
+2K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+3K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+3K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+3K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+3K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+3K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+3K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K201315PERFORM Humeral System – StemTornier, Inc.2020111
+3K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+3K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+3K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K152966Aequalis Fx2Tornier S.A.S.201601
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—