510(k) Report

Devices descending from K952928

393 later devices reach Aequalis Shoulder System for Total & Hemishoulder Applications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+3K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+3K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+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—
+3K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+3K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+3K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+3K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+3K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+3K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+3K142139SMR 40MM GlenosphereLima Corporate S.P.A.201413—
+3K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+3K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+3K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+3K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+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—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+3K113413Ascend Shoulder SystemTornier, Inc.2012105—
+3K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+3K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K103251Duocentric ReversedAston Medical20117—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K110598SMR Reverse Shoulder SystemLima Corporate S.P.A.2011441
+3K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+3K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+3K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+3K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+3K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+3K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+3K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+3K070565Cofield Total Shoulder SystemSmith & Nephew, Inc.200726—
+3K060694Modular Hybrid GlenoidBiomet Manufacturing Corp2006574
+3K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+3K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+3K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+3K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+3K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.200561
+3K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc.20051761
+3K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+3K032895BI-Angular Shoulder SystemBiomet, Inc.200310—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+4K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+4K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+4K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+4K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K243509Archer PSI System3D-Side20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—