510(k) Report

Devices descending from K100142

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+5K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+5K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+5K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+5K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+5K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+5K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+6K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—