510(k) Report

Devices descending from K012506

61 later devices reach Mastergraft Resorbable Ceramic Granules through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+1K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+1K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+1K023553Mastergraft MatrixMedtronic Sofamor Danek, Inc.200339—
+2K260364Device 300419 StripGeistlich Pharma AG20260—
+2K241802Device 300397 PuttyGeistlich Pharma AG20241—
+2K223915TactosetAnika Therapeutics, Inc.20231—
+2K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+2K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC20201—
+2K162860MCS Bone GraftBioventus, LLC20170—
+2K160446MCP Bone PuttyBiostructures, LLC20161—
+2K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+2K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+2K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+2K082166Mastergraft StripMedtronic Sofamor Danek200938—
+2K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+2K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+2K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+2K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+3K251556Device 300423 GranulesGeistlich Pharma AG20250—
+3K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+3K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+3K240765Porous Biologic ScaffoldVentris Medical20240—
+3K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+3K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+3K230486Cove StripSeaSpine Orthopedics Corporation20231—
+3K221644Synthetic Bone PuttyVentris Medical20220—
+3K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+3K212991OsteoreviveBone Solutions, Inc.20221—
+3K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+3K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+3K200640Altapore ShapeBaxter Healthcare Corporation20201—
+3K192363AltaporeBaxter Healthcare Corporation20204—
+3K191513Altapore ShapeBaxter Healthcare Corporation20192—
+3K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+3K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+3K181721Ceracell Ortho FoamCurasan AG20180—
+3K181225AltaporeBaxter Healthcare Corporation20186—
+3K173525NovoGroOsteonovus, Inc.20180—
+3K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+3K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+3K141824Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc.20140—
+3K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+3K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+3K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+3K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+3K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+4K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+4K233259XerosynXerothera, Inc.20240—
+4K240453ReBOSSISOrthorebirth Co., Ltd.202402
+4K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation20230—
+4K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+4K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+4K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+4K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+4K201464Altapore MISBaxter Healthcare Corporation20201—
+4K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K243474MagnetOs MISKuros Biosciences B.V20250—