510(k) Report

Devices descending from K122698

96 later devices reach Aequalis Ascend Flex Shoulder System through their predicates, nearest generation first.

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