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
+1K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+1K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+1K111902Aequalis Shoulder SystemTornier201149—
+1K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+1K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+1K081059Aequalis Reversed Shoulder ProsthesisTornier2008179—
+1K062661Aequalis Resurfacing HeadTornier200616—
+1K063081Aequalis Shoulder SystemTornier2006162—
+1K061439Aequalis Reversed ProsthesisTornier2006199—
+1K060209Aequalis Shoulder Fracture System & Aequalis Shoulder SystemTornier2006257—
+1K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+1K043077Modification to Aequalis Shoulder Fracture System; Aequalis Shoulder SystemTornier2004258—
+1K041873Aequalis Reversed Shoulder ProsthesisTornier2004277—
+1K041339Aequalis Shoulder SystemTornier2004259—
+1K030941Aequalis Reversed Shoulder ProsthesisTornier2004280—
+1K032679Aequalis Shoulder Fracture SystemTornier2003287—
+1K030344Modular Neer 3 Humeral Stems and Modular Neer 3 Humeral HeadsSmith & Nephew, Inc.20030—
+1K992899Bio-Modular Shoulder Offset Humeral HeadsBiomet, Inc.1999254—
+1K980244Aequalis Shoulder ProsthesisTornier1999160—
+2K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+2K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+2K193175Lateralized GlenosphereMedacta Inernational SA20201—
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+2K181420Aequalis Flex Revive Shoulder SystemTornier, Inc.20184—
+2K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+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
+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—
+2K141345Aequalis FX2Tornier S.A.S.201411
+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—
+2K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+2K130635Seviin Surface Replacement ShoulderIngen Orthopedics, LLC20130—
+2K120374Seviin Reverse ShoulderIngen Orthopedics, LLC20121—
+2K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+2K111212SMR Shoulder System- Revision StemsLima Corporate S.P.A.201133—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+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—
+2K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+2K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+2K071948Aequalis Reversed AdapterTornier2007178—
+2K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+2K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+2K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+2K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+2K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+2K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp20059—
+2K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+2K030710Bio-Modular Shoulder SystemBiomet, Inc.20032531
+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—
+3K241609Tornier Humeral Reconstruction System (Tornier HRS)Stryker Corporation (Tornier, Inc.)20240—
+3K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+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—
+3K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+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
+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—
+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—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+3K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+3K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+3K191814Alliance GlenoidZimmer, Inc.20194—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+3K191318AEQUALIS FLEX REVIVE Shoulder SystemTornier, Inc.201932
+3K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+3K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941