510(k) Report

Devices descending from K052494

123 later devices reach Novabone-Bioactive Synthetic Graft through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132805BG MorselsProsidyan, Inc.201433—
+1K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC200871—
+1K070998Inion BiorestoreInion OY20074—
+1K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+1K053387Perioglas Bone Graft ParticulateNovabone Products, LLC200613—
+2K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+2K191764Inion BioRestoreInion OY20190—
+2K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+2K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+2K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+2K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+2K133678Confirm BioactiveGlobus Medical, Inc.20140—
+2K140844Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc.20141—
+2K130977Signify BioactiveGlobus Medical, Inc.20131—
+2K130392Kinex BioactiveGlobus Medical, Inc.20138—
+2K111105Curasan Osseolive DentalCurasan AG20120—
+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—
+2K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+2K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+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—
+2K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+2K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+2K071937Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20070—
+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—
+3K240450Citrepore™Acuitive Technologies, Inc.20240—
+3K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+3K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+3K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+3K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+3K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+3K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+3K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+3K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+3K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC20180—
+3K173008SCS 17-01Anika Therapeutics, Inc.20174—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K163310NovaBone IRMNovabone Products, LLC20170—
+3K160978LITe BIO Delivery SystemStryker Corporation20160—
+3K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+3K141207Novabone Bioactive StripNovabone Products, LLC20140—
+3K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+3K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+3K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+3K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+3K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+3K090387Kainos+Signus Medizintechnik GmbH20090—
+3K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+3K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+3K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+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—
+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—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+4K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+4K223915TactosetAnika Therapeutics, Inc.20231—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+4K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+4K190956SCS 17-01Anika Therapeutics, Inc.20203—
+4K190371Morpheus-CBiogennix, LLC20190—
+4K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+4K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+4K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+4K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+4K130703Vivorte BVFVivorte, Inc.201311
+4K113049Socket GraftSteiner Laboratories20120—
+4K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+4K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+4K093447CarrigenEtex Corp.201021—
+5K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K243474MagnetOs MISKuros Biosciences B.V20250—