510(k) Report

Devices descending from K980244

160 later devices reach Aequalis Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+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—
+6K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+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
+6K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+6K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+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—
+7K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+7K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+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—
+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
+7K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+7K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+7K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+8K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+8K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+8K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+8K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+8K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+9K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+9K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+10K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+11K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—