510(k) Report

Devices descending from K990131

224 later devices reach Pro Osteon Implant 500R Resorbable Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180853EP Granules™ BVFElute, Inc.20181—
+1K093342Biogennix RPCBiogennix, LLC20105—
+1K063157Merries K-Phate Bone Graft SubstituteMerries International, Inc.20080—
+1K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+1K063346Pro Osteon 500REbi, L.P.20070—
+1K070220Osteofix Bone Void FillerCalcitec, Inc.20070—
+1K060432Novabone Porous-Bone Graft ScaffoldNovabone Products, LLC200619—
+1K050025Nanoss Bone Void FillerAngstrom Medica, Inc.200511—
+1K041089Oss Bone Graft System and Oss Rapidset Bone Graft SystemBiomet Manufacturing, Inc.20040—
+1K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc.200454—
+1K040646Straumann GranulesThe Straumann Co.20042—
+1K033611Calcigen -Nap Bone Void FillerBiomet, Inc.20040—
+1K032268MBCPBiomatlante2003142—
+1K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc.20033—
+1K020986Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc.2002158—
+1K013960Apatight HA-Bone Graft SubstituteCerabio, LLC20024—
+1K014053Conduit TCP GranulesDepuyacromed20027—
+1K012751Healos Bone Graft MaterialOrquest, Inc.200184—
+2K250346BonVie+Elute, Inc.20250—
+2K201051Straumann BoneCeramicInstitut Straumann AG20200—
+2K172237Bicera Resorbable Bone SubstituteWiltrom Corporation Limited20180—
+2K161859MagnetOsXpand Biotechnology BV201712—
+2K141725Bongold Bone Graft MaterialBeijing Allgens Medical Science & Technology Co, L20151—
+2K141189Nanobone / GranulateArtoss GmbH20152—
+2K142828osteoSPAN MorpheusBiogennix20152—
+2K141207Novabone Bioactive StripNovabone Products, LLC20140—
+2K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+2K132377Osteospan MorpheusBiogennix, LLC20144—
+2K110949Bicera (TM) Resorbable Bone SubstituteWiltrom Corporation Limited20123—
+2K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+2K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+2K090387Kainos+Signus Medizintechnik GmbH20090—
+2K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+2K082918Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek20091—
+2K082917Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek20093—
+2K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+2K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+2K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+2K071876Cross.BoneTriMed, Inc.20070—
+2K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+2K070998Inion BiorestoreInion OY20074—
+2K071237Copios Bone Void Filler Sponge and PasteKensey Nash Corp.20074—
+2K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+2K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+2K051047Colloss E Bone Void FillerOssacur AG20060—
+2K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+2K051774MBCPBiomatlante200660—
+2K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+2K051722Tricos TBaxter Healthcare Corp20053—
+2K051885MBCPBiomatlante200559—
+2K051775Osteomimetic Synthetic Bone MatrixBiomimetic Pharmaceuticals, Inc.20050—
+2K050170Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd.20050—
+2K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511—
+2K043005Modification to MBCPBiomatlante2005122—
+2K050357Camceram TCPCam Implants B.V.20051—
+2K050490Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea20050—
+2K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.200567—
+2K033258Bonesave Bone Void FillerHowmedica Osteonics20043—
+2K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc.20031—
+2K023553Mastergraft MatrixMedtronic Sofamor Danek, Inc.200339—
+3K260364Device 300419 StripGeistlich Pharma AG20260—
+3K244006FG Bone Graft MFull Golden Biotech Co., Ltd.20250—
+3K241802Device 300397 PuttyGeistlich Pharma AG20241—
+3K223915TactosetAnika Therapeutics, Inc.20231—
+3K220337GaiaBone Bioabsorbable Bone GraftCorliber (Shenzhen) Medical Device Co., Ltd.20230—
+3K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+3K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+3K213111MagnetOs granulesKuros Biosciences B.V20227—
+3K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+3K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC20201—
+3K193487Agilon StripBiogennix, LLC20200—
+3K193168Agilon MoldableBiogennix, LLC20200—
+3K190371Morpheus-CBiogennix, LLC20190—
+3K191764Inion BioRestoreInion OY20190—
+3K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+3K171629ABCcolla Bone GraftAcro Biomedical Co., Ltd.20181—
+3K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+3K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials201701
+3K171563MagnetOs PuttyKuros Biosciences B.V20174—
+3K162860MCS Bone GraftBioventus, LLC20170—
+3K160446MCP Bone PuttyBiostructures, LLC20161—
+3K161351NanoBone SBX PuttyArtoss GmbH20161—
+3K153676Osteon IiiGenoss Co., Ltd.20160—
+3K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+3K142276MCS Bone GraftBiostructures, LLC20153—
+3K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+3K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+3K132071Bioactive Bone Graft PuttyBiostructures, LLC201461
+3K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+3K103820Reprobone Dental Grafting MaterialCeramisys, Ltd.20110—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K102937Osteophil Beta-TCPCytophil, Inc.20100—
+3K100986Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationSkeletal Kinetics, LLC2010011
+3K090950Bone Plus BCPMegagen Implant Co., Ltd.20101—
+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—
+3K093871Periophil B-TCPCytophil, Inc.20100—
+3K093122MBCP+Biomatlante20100—
+3K092087Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc.20090—
+3K092788Periophil BiphasicCytophil, Inc.200901