510(k) Report

Devices descending from K041873

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+1K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+1K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+1K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+1K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+1K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+1K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+1K071948Aequalis Reversed AdapterTornier2007178—
+1K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+1K061439Aequalis Reversed ProsthesisTornier2006199—
+1K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+1K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+1K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+2K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+2K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+2K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+2K193175Lateralized GlenosphereMedacta Inernational SA20201—
+2K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+2K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+2K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+2K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+2K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+2K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+2K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+2K162455Humelock Reversed ShoulderFx Solutions201717—
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+2K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+2K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+2K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+2K141345Aequalis FX2Tornier S.A.S.201411
+2K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+2K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+2K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+2K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+2K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+2K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+2K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+2K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+2K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+2K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+2K121714Smith & Nephew, Inc. Shoulder System InstrumentsSmith & Nephew, Inc.20120—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K103251Duocentric ReversedAston Medical20117—
+2K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+2K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+2K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+2K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+2K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+3K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+3K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+3K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+3K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+3K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+3K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+3K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—