510(k) Report

Devices descending from K802123

415 later devices reach Monospherical Shoulder Prosthesis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+5K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+5K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K192967Medacta Shoulder SystemMedacta International S.A.20200—
+5K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+5K193099Anatomical Shoulder SystemZimmer GmbH20201—
+5K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+5K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+5K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+5K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+5K183696Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.201941
+5K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+5K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K172633INFINITY Total Ankle SystemWrightmedicaltechnologyinc20182—
+5K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+5K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+5K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+5K163669Humeris ShoulderFx Solutions201720—
+5K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+5K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+5K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+5K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+5K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+5K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+5K140652Porous Coated Comprehensive Fracture StemsBiomet Manufacturing Corp20140—
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K141006RSP Humeral Socket InsertDjo Global2014212
+5K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+5K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+5K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+5K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K131633Arthrex Univers ApexArthrex, Inc.20134—
+5K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+5K131129Cas Psi ShoulderZimmer Cas201339—
+5K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+5K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+5K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+5K120794Ascend Shoulder SystemTornier, Inc.201298—
+5K113413Ascend Shoulder SystemTornier, Inc.2012105—
+5K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+5K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+5K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+5K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+5K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+5K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+5K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+5K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+5K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+6K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+6K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+6K260556Veritas Shoulder SystemRestor3D20260—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P.20260—
+6K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+6K252141AltiVate Reverse® GlenoidEncore Medical L.P.20250—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K241491Blueprint Patient-Specific Instrumentation; Shoulder iD Primary Reversed GlenoidStryker Corporation (Tornier, S.A.S.)20241—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K232265BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.20243—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+6K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—