510(k) Report

Devices descending from K021336

162 later devices reach Novabone-Resorbable Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112857Interface Bone Void FillerBiostructures, LLC20118—
+1K092541InterfaceBiostructures20109—
+1K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC200871—
+1K071199Bonalive GranulesVivoxid, Ltd.20088—
+1K070998Inion BiorestoreInion OY20074—
+1K062459Origen DBM with Bioactive GlassNanotherapeutics200756—
+1K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006120—
+1K060432Novabone Porous-Bone Graft ScaffoldNovabone Products, LLC200619—
+1K051617Novabone Putty - Resorbable Bone Void FillerNovabone Products, LLC20065—
+1K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613—
+1K052494Novabone-Bioactive Synthetic GraftNovabone Products, LLC2005123—
+1K050025Nanoss Bone Void FillerAngstrom Medica, Inc.200511—
+1K041613Novabone - AR - Resorbable Bone Graft SubstituteNovabone Products, LLC200484—
+2K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+2K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+2K191274BonAlive GranulesBonalive Biomaterials, Ltd.20197—
+2K191764Inion BioRestoreInion OY20190—
+2K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+2K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+2K141189Nanobone / GranulateArtoss GmbH20152—
+2K141207Novabone Bioactive StripNovabone Products, LLC20140—
+2K133678Confirm BioactiveGlobus Medical, Inc.20140—
+2K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+2K140844Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc.20141—
+2K132805BG MorselsProsidyan, Inc.201433—
+2K132071Bioactive Bone Graft PuttyBiostructures, LLC201461
+2K130977Signify BioactiveGlobus Medical, Inc.20131—
+2K130392Kinex BioactiveGlobus Medical, Inc.20138—
+2K122868Biosphere Bioactive Bone Graft PuttySynergy Biomedical, LLC20133—
+2K111105Curasan Osseolive DentalCurasan AG20120—
+2K120279Nanofuse DBMNanotherapeutics20122—
+2K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+2K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC201138—
+2K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+2K110976Origen DBM with Bioactive Glass, Nanofuse DBMNanotherapeutics, Inc.201132
+2K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+2K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+2K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+2K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+2K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY20092—
+2K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+2K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+2K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+2K071937Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20070—
+2K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+2K070055Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20071—
+2K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074—
+2K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+3K253883Bonalive MaxillofacialBonalive, Ltd.20260—
+3K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+3K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+3K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+3K231528Bonalive Orthopedics granulesBonalive Biomaterials, Ltd.20236—
+3K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+3K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+3K221644Synthetic Bone PuttyVentris Medical20220—
+3K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+3K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+3K190371Morpheus-CBiogennix, LLC20190—
+3K173424BioSphere FlexSynergy Biomedical20180—
+3K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+3K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC20180—
+3K173008SCS 17-01Anika Therapeutics, Inc.20174—
+3K171563MagnetOs PuttyKuros Biosciences B.V20174—
+3K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K163310NovaBone IRMNovabone Products, LLC20170—
+3K161351NanoBone SBX PuttyArtoss GmbH20161—
+3K160978LITe BIO Delivery SystemStryker Corporation20160—
+3K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+3K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+3K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+3K142104Nanofuse DBMNanotherapeutics, Inc.20151—
+3K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+3K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+3K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+3K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+3K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+3K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+3K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+3K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+3K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+4K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+4K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+4K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+4K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K242782GlassBone GranulesNoraker20240—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty…Orthocon, Inc.20240—
+4K240450Citrepore™Acuitive Technologies, Inc.20240—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—