510(k) Report

Devices descending from K974399

172 later devices reach Bio-Oss Collagen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K092194Polybone DentalKyung Won Medical Co., Ltd.20100—
+3K092608Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc.20100—
+3K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+3K092087Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc.20090—
+3K083372Arrowbone-a, Arrowbone-BBrainbase Corporation20091—
+3K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+3K082166Mastergraft StripMedtronic Sofamor Danek200938—
+3K090793Bongros HABioalpha, Inc.20090—
+3K081717Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp20080—
+3K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+3K081721Tricos a Resorbable SubstituteBaxter Healthcare Corp20080—
+3K081561Osferion DOlympus Terumo Biomaterials Corporation20081—
+3K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+3K072384Modification to Copios Bone Void Filler Sponge & PasteKensey Nash Corp.20070—
+3K062102OdoncerTeknimed, S.A.20070—
+3K053374Ossaplast Dental (Particle Size of 500 to 1000 UM to 2000 UM)Ossacur AG20062—
+4K253317Cytrans™ ElashieldGC America, Inc.20260—
+4K250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.20250—
+4K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG20250—
+4K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…Geistlich Pharma AG20250—
+4K251556Device 300423 GranulesGeistlich Pharma AG20250—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AG20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K240765Porous Biologic ScaffoldVentris Medical20240—
+4K233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc.20240—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+4K230486Cove StripSeaSpine Orthopedics Corporation20231—
+4K221644Synthetic Bone PuttyVentris Medical20220—
+4K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+4K212991OsteoreviveBone Solutions, Inc.20221—
+4K212156ABCcolla Bone MatrixAcro Biomedical Co., Ltd.20210—
+4K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+4K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+4K200640Altapore ShapeBaxter Healthcare Corporation20201—
+4K191737The Graft Bone SubstitutePurgo Biologics, Inc.20200—
+4K192363AltaporeBaxter Healthcare Corporation20204—
+4K191513Altapore ShapeBaxter Healthcare Corporation20192—
+4K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+4K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+4K181721Ceracell Ortho FoamCurasan AG20180—
+4K181225AltaporeBaxter Healthcare Corporation20186—
+4K173525NovoGroOsteonovus, Inc.20180—
+4K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+4K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+4K141824Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc.20140—
+4K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+4K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+4K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+4K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+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—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K233259XerosynXerothera, Inc.20240—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation20230—
+5K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+5K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+5K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+5K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+5K201464Altapore MISBaxter Healthcare Corporation20201—
+5K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+5K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K243474MagnetOs MISKuros Biosciences B.V20250—