510(k) Report

Devices descending from K011942

111 later devices reach Aequalis Press-Fit Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+5K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K163669Humeris ShoulderFx Solutions201720—
+5K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+5K141345Aequalis FX2Tornier S.A.S.201411
+5K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+5K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K250644MSS - Monobloc stemMedacta International S.A.202611
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+6K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+6K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+6K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+6K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+6K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+6K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+6K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+6K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+6K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+6K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+6K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K152966Aequalis Fx2Tornier S.A.S.201601
+7K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+7K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+7K254003JARVIS Metaphyseal StemFH Industrie20260—
+7K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+7K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+7K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K243248Inhance Intact™Depuy Ireland UC20240—
+7K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K240876Identity Shoulder SystemZimmer, Inc.20241—
+7K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+7K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+7K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+7K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+7K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+7K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+7K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+7K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+7K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K260583Equinoxe® Shoulder SystemExactech, Inc.20260—