510(k) Report

Devices descending from K991585

414 later devices reach Bipolar Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+4K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+4K201315PERFORM Humeral System – StemTornier, Inc.2020111
+4K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+4K192967Medacta Shoulder SystemMedacta International S.A.20200—
+4K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+4K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+4K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+4K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+4K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+4K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+4K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+4K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+4K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+4K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+4K163669Humeris ShoulderFx Solutions201720—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+4K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+4K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+4K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+4K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+4K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+4K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+4K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K131633Arthrex Univers ApexArthrex, Inc.20134—
+4K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+4K131129Cas Psi ShoulderZimmer Cas201339—
+4K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+4K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+4K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+4K120794Ascend Shoulder SystemTornier, Inc.201298—
+4K113413Ascend Shoulder SystemTornier, Inc.2012105—
+4K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+4K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+4K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+4K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+4K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+4K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+4K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+4K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+4K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+5K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+5K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+5K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+5K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+5K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+5K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+5K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+5K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+5K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+5K243248Inhance Intact™Depuy Ireland UC20240—
+5K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+5K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+5K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+5K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+5K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+5K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+5K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—