510(k) Report

Devices descending from K030941

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K201315PERFORM Humeral System – StemTornier, Inc.2020111
+3K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+3K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+3K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+3K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+3K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K141006RSP Humeral Socket InsertDjo Global2014212
+3K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+3K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+3K133462Duocentric Reversed Shoulder ProsthesisAston Medical20140—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+3K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+3K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+3K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+3K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+3K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+3K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+3K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+3K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+3K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+4K254003JARVIS Metaphyseal StemFH Industrie20260—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+4K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+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—
+4K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+4K241043Augment Off-Axis Instrument SystemFix Surgical202415
+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—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+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—
+4K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—