510(k) Report

Devices descending from K012212

246 later devices reach Modification to Aequalis Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+5K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+5K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+5K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+6K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+6K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+6K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+6K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+6K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+6K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+6K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+6K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+6K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+6K163669Humeris ShoulderFx Solutions201720—
+6K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+7K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+7K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+7K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+7K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+7K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+7K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+7K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+7K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+7K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+7K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+8K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+8K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+8K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+8K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+8K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+9K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—