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
+1K062691ComporusTakiron Co., Ltd.20080—
+1K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+1K063346Pro Osteon 500REbi, L.P.20070—
+1K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc.200454—
+1K033611Calcigen -Nap Bone Void FillerBiomet, Inc.20040—
+1K030288Polygraft Bone Graft SubstituteOsteobiologics, Inc.200333—
+1K030131Ossatura BCP Bone Void FillerIsotis NV2003133—
+1K021336Novabone-Resorbable Bone Graft SubstituteNovabone Products, LLC2002162—
+1K013960Apatight HA-Bone Graft SubstituteCerabio, LLC20024—
+1K012751Healos Bone Graft MaterialOrquest, Inc.200184—
+1K000515Pro Osteon 200R Resorbable Bone Graft Substitute, Models 2RG051, 2RG101, 2RG151, 2RG201…Interpore Cross Intl.200085—
+2K161859MagnetOsXpand Biotechnology BV201712—
+2K141725Bongold Bone Graft MaterialBeijing Allgens Medical Science & Technology Co, L20151—
+2K112857Interface Bone Void FillerBiostructures, LLC20118—
+2K092541InterfaceBiostructures20109—
+2K090641CuriosProgentix Orthobiology BV200979—
+2K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+2K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+2K073303Norian DrillableSynthes (Usa)200813
+2K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC200871—
+2K071199Bonalive GranulesVivoxid, Ltd.20088—
+2K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+2K062607Polygraft BGSSmith & Nephew, Inc.20070—
+2K070998Inion BiorestoreInion OY20074—
+2K070794AtlantikMedical Biomat20070—
+2K071237Copios Bone Void Filler Sponge and PasteKensey Nash Corp.20074—
+2K062459Origen DBM with Bioactive GlassNanotherapeutics200756—
+2K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+2K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+2K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006120—
+2K060432Novabone Porous-Bone Graft ScaffoldNovabone Products, LLC200619—
+2K060285Bonegen - TRBio-Lok Intl., Inc.20061—
+2K051047Colloss E Bone Void FillerOssacur AG20060—
+2K051617Novabone Putty - Resorbable Bone Void FillerNovabone Products, LLC20065—
+2K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613—
+2K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+2K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+2K052494Novabone-Bioactive Synthetic GraftNovabone Products, LLC2005123—
+2K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511—
+2K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.200567—
+2K050025Nanoss Bone Void FillerAngstrom Medica, Inc.200511—
+2K040047Polygraft BGS; Bone Graft SubstituteOsteobiologics, Inc.2004231
+2K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC200484—
+2K033707Polygraft TCP Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-XX, 600-025-XX…Osteobiologics, Inc.200410—
+2K040082Pore-SI Bone Graft SubstituteApatech, Ltd.2004113—
+2K033722Apapore Bone Graft SubstituteApatech, Ltd.200413—
+2K040646Straumann GranulesThe Straumann Co.20042—
+2K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc.20033—
+3K260364Device 300419 StripGeistlich Pharma AG20260—
+3K241802Device 300397 PuttyGeistlich Pharma AG20241—
+3K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+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—
+3K201051Straumann BoneCeramicInstitut Straumann AG20200—
+3K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+3K191974NuVasive AttraX PuttyNu Vasive, Incorporated201971—
+3K191274BonAlive GranulesBonalive Biomaterials, Ltd.20197—
+3K191764Inion BioRestoreInion OY20190—
+3K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+3K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials201701
+3K171563MagnetOs PuttyKuros Biosciences B.V20174—
+3K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+3K162860MCS Bone GraftBioventus, LLC20170—
+3K160446MCP Bone PuttyBiostructures, LLC20161—
+3K151584AttraX PuttyProgentix Orthobiology BV201576—
+3K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+3K141189Nanobone / GranulateArtoss GmbH20152—
+3K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+3K141207Novabone Bioactive StripNovabone Products, LLC20140—
+3K133678Confirm BioactiveGlobus Medical, Inc.20140—
+3K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+3K140844Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc.20141—
+3K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+3K132805BG MorselsProsidyan, Inc.201433—
+3K132071Bioactive Bone Graft PuttyBiostructures, LLC201461
+3K130977Signify BioactiveGlobus Medical, Inc.20131—
+3K130392Kinex BioactiveGlobus Medical, Inc.20138—
+3K122868Biosphere Bioactive Bone Graft PuttySynergy Biomedical, LLC20133—
+3K111105Curasan Osseolive DentalCurasan AG20120—
+3K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+3K120279Nanofuse DBMNanotherapeutics20122—
+3K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+3K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC201138—
+3K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+3K102208NanogenOrthogen, LLC20110—
+3K110976Origen DBM with Bioactive Glass, Nanofuse DBMNanotherapeutics, Inc.201132
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+3K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+3K102722Norian Drillable Inject, Norian Drillable Fast Set PuttySynthes USA Products, LLC201104
+3K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+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—
+3K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+3K090850Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteApatech, Ltd.200901