510(k) Report

Devices descending from K052472

158 later devices reach Depuy Global Shoulder Crosslink Glenoid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+1K110905Total Shoulder SystemShoulder Innovations, LLC20110—
+1K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+1K092122Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc.200975—
+1K060694Modular Hybrid GlenoidBiomet Manufacturing Corp2006574
+2K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+2K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+2K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+2K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+2K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+2K191814Alliance GlenoidZimmer, Inc.20194—
+2K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+2K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+2K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+2K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+2K130759Humelock II Cementless Shoulder SystemFx Solutions201331—
+2K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K091196GRS Glenoid Resurfacing SystemArthrosurface, Inc.200923—
+3K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+3K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K241470CORE Shoulder SystemLinkBio Corp.202501
+3K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K243248Inhance Intact™Depuy Ireland UC20240—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+3K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K160975Aequalis PerFORM+ Shoulder SystemTornier, Inc.20167—
+3K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+3K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+3K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+3K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+3K131129Cas Psi ShoulderZimmer Cas201339—
+3K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+3K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+4K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+4K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K163669Humeris ShoulderFx Solutions201720—
+4K162697Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative…Custom Orthopaedic Solutions, Inc.20175—
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K151500Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)Custom Orthopaedic Solutions20157—
+4K151501OrthoVis Web PortalCustom Orthopaedic Solutions, Inc.20157—
+4K151568Arthrex OrthoVis Preoperative PlanCustom Orthopaedic Solutions, Inc.201520—
+4K150730Zimmer PSI Shoulder SystemZimmer201511—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K222007Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20233—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+5K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K193523ArthrexVIP Web PortalArthrex, Inc.20200—
+5K190738MyShoulder Placement GuidesMedacta International S.A.20194—
+5K190595Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)201910—
+5K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+5K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho2017151
+5K161789BLUEPRINT Patient Specific InstrumentationTornier S.A.S.20160—
+5K160555BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201625—
+5K153612ArthrexVIP Web PortalCustom Orthopaedic Solutions, Inc.20160—
+5K153215SmartBase for Arthrex Glenoid IRISCustom Orthopaedic Solutions, Inc.20160—
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—