510(k) Report

Devices descending from K012212

246 later devices reach Modification to Aequalis Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+1K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+1K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+1K062661Aequalis Resurfacing HeadTornier200616—
+1K061439Aequalis Reversed ProsthesisTornier2006199—
+1K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+2K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+2K193175Lateralized GlenosphereMedacta Inernational SA20201—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+2K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+2K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+2K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+2K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+2K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+2K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+2K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+2K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+2K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+2K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+2K071948Aequalis Reversed AdapterTornier2007178—
+2K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+2K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+3K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+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—
+3K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+3K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+3K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+3K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient…Tornier, Inc.202182
+3K213124Tomier Perform™ Reversed Glenoid Cannulated GlenospheresTornier, Inc.20211—
+3K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+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—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+3K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+3K112983Spacer-STecres S.P.A.20117—
+3K103251Duocentric ReversedAston Medical20117—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212