510(k) Report

Devices descending from K060209

257 later devices reach Aequalis Shoulder Fracture System & Aequalis Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141345Aequalis FX2Tornier S.A.S.201411
+1K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+1K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+1K111902Aequalis Shoulder SystemTornier201149—
+1K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+1K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+1K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+1K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+1K062661Aequalis Resurfacing HeadTornier200616—
+1K063081Aequalis Shoulder SystemTornier2006162—
+1K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+1K061439Aequalis Reversed ProsthesisTornier2006199—
+2K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+2K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+2K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+2K193175Lateralized GlenosphereMedacta Inernational SA20201—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+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
+2K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+2K152966Aequalis Fx2Tornier S.A.S.201601
+2K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+2K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+2K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+2K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+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—
+2K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+2K131298Exactech Equinoxe Resurfacing Humeral Head SystemExactech, Inc.20138—
+2K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+2K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+2K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+2K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+2K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+2K071948Aequalis Reversed AdapterTornier2007178—
+2K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+3K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K240876Identity Shoulder SystemZimmer, Inc.20241—
+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—
+3K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+3K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+3K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+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—
+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—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K193099Anatomical Shoulder SystemZimmer GmbH20201—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+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—
+3K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+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—
+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
+3K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+3K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+3K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+3K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+3K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—