510(k) Report

Devices descending from K061439

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+4K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWrightmedicaltechnologyinc20190—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K181557INFINITY Total Ankle SystemWrightmedicaltechnologyinc20180—
+4K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+4K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+4K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+4K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+4K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K253674Blueprint Patient-Specific InstrumentationStryker Corporation (Tornier, S.A.S.)20260—
+5K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20261—
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+5K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+5K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+5K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+5K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K163669Humeris ShoulderFx Solutions201720—
+5K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS20260—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+6K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+6K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+6K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+6K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+6K203375OVOMotion Reverse Shoulder Arthroplasty SystemArthrosurface, Inc.20210—
+6K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20202—
+6K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+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—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—
+7K252352SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.20260—
+7K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+7K243248Inhance Intact™Depuy Ireland UC20240—
+7K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+7K223801FX V135(TM) Shoulder ProsthesisFx Shoulder USA, Inc.20232—
+7K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+8K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—