510(k) Report

Devices descending from K012751

84 later devices reach Healos Bone Graft Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141725Bongold Bone Graft MaterialBeijing Allgens Medical Science & Technology Co, L20151—
+1K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+1K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+1K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+1K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+1K051047Colloss E Bone Void FillerOssacur AG20060—
+1K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+1K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+1K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511—
+1K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.200567—
+1K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc.200454—
+2K260364Device 300419 StripGeistlich Pharma AG20260—
+2K241802Device 300397 PuttyGeistlich Pharma AG20241—
+2K223915TactosetAnika Therapeutics, Inc.20231—
+2K220337GaiaBone Bioabsorbable Bone GraftCorliber (Shenzhen) Medical Device Co., Ltd.20230—
+2K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+2K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC20201—
+2K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+2K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials201701
+2K162860MCS Bone GraftBioventus, LLC20170—
+2K160446MCP Bone PuttyBiostructures, LLC20161—
+2K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K092608Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc.20100—
+2K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+2K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+2K082166Mastergraft StripMedtronic Sofamor Danek200938—
+2K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+2K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+2K071237Copios Bone Void Filler Sponge and PasteKensey Nash Corp.20074—
+2K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+3K251556Device 300423 GranulesGeistlich Pharma AG20250—
+3K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+3K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+3K240765Porous Biologic ScaffoldVentris Medical20240—
+3K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+3K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+3K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+3K230486Cove StripSeaSpine Orthopedics Corporation20231—
+3K213260CMFlexTMDimension Inx Corp.20220—
+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—
+3K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+3K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+3K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+3K072384Modification to Copios Bone Void Filler Sponge & PasteKensey Nash Corp.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—
+4K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+4K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+4K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+4K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+4K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+5K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+7K243474MagnetOs MISKuros Biosciences B.V20250—