510(k) Report

Devices descending from K082120

164 later devices reach Aequalis Reversed Fracture Shoulder Prothesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K201315PERFORM Humeral System – StemTornier, Inc.2020111
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+4K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+4K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+4K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+4K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+4K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+4K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+4K163669Humeris ShoulderFx Solutions201720—
+4K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+4K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+5K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+5K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+5K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+5K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+5K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+5K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+5K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+6K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+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—
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+6K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+6K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+6K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+6K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+6K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+7K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+7K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+7K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+8K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—