510(k) Report

Devices descending from K980817

312 later devices reach Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K082166Mastergraft StripMedtronic Sofamor Danek200938—
+3K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+3K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+3K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY20092—
+3K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+3K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+3K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+3K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+3K071912Apaceram Bone Graft SubstitutePentax Corp.20071—
+3K071937Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20070—
+3K072384Modification to Copios Bone Void Filler Sponge & PasteKensey Nash Corp.20070—
+3K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+3K070055Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20071—
+3K071206Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd.20071111
+3K063359INQUIsto Technologies, Inc.200713—
+3K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074—
+3K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+3K051951Cerament Bone Void FillerBonesupport AB200510—
+3K050170Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd.20050—
+3K050490Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea20050—
+3K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc.20031—
+4K253883Bonalive MaxillofacialBonalive, Ltd.20260—
+4K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+4K251556Device 300423 GranulesGeistlich Pharma AG20250—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K240765Porous Biologic ScaffoldVentris Medical20240—
+4K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K230736MagnetOs PuttyKuros Biosciences B.V20234—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+4K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+4K230486Cove StripSeaSpine Orthopedics Corporation20231—
+4K231528Bonalive Orthopedics granulesBonalive Biomaterials, Ltd.20236—
+4K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221644Synthetic Bone PuttyVentris Medical20220—
+4K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+4K212991OsteoreviveBone Solutions, Inc.20221—
+4K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+4K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+4K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+4K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+4K200640Altapore ShapeBaxter Healthcare Corporation20201—
+4K192363AltaporeBaxter Healthcare Corporation20204—
+4K191513Altapore ShapeBaxter Healthcare Corporation20192—
+4K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+4K190371Morpheus-CBiogennix, LLC20190—
+4K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+4K181721Ceracell Ortho FoamCurasan AG20180—
+4K173424BioSphere FlexSynergy Biomedical20180—
+4K181225AltaporeBaxter Healthcare Corporation20186—
+4K173525NovoGroOsteonovus, Inc.20180—
+4K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+4K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC20180—
+4K170165Osteo-P Bone Graft SubstituteMolecular Matrix, Inc.20170—
+4K173008SCS 17-01Anika Therapeutics, Inc.20174—
+4K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+4K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+4K170620ReBOSSIS85Orthorebirth Co., Ltd.201702
+4K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+4K162087NovoGroOsteonovus, Inc.20170—
+4K163310NovaBone IRMNovabone Products, LLC20170—
+4K161351NanoBone SBX PuttyArtoss GmbH20161—
+4K160978LITe BIO Delivery SystemStryker Corporation20160—
+4K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+4K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+4K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+4K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+4K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+4K142104Nanofuse DBMNanotherapeutics, Inc.20151—
+4K141824Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc.20140—
+4K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+4K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+4K132377Osteospan MorpheusBiogennix, LLC20144—
+4K130531UltrafuseBaxter Healthcare Corp20147—
+4K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+4K120602Apaceram Bone Graft SubstituteHoya Corporation20120—
+4K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+4K111838Inqu Paste MixIsto Technologies, Inc.20110—
+4K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+4K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+4K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+4K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+4K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+4K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+4K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+4K071004Osteocrete Bone Void FillerBone Solutions, Inc.20092—
+4K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+4K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+4K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+4K082073Actifuse Flow Bone Graft SubstituteApatech, Ltd.20084—
+4K073316Cerament Bone Void Filler, Model A0210Bonesupport AB20086—
+4K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+4K080736Actifuse Shape Bone Graft SubstituteApatech, Ltd.200879—
+4K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+4K071428INQUIsto Technologies, Inc.200711—