510(k) Report

Devices descending from K041613

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141189Nanobone / GranulateArtoss GmbH20152—
+1K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+1K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+1K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+1K051617Novabone Putty - Resorbable Bone Void FillerNovabone Products, LLC20065—
+2K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+2K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+2K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+2K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+2K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+2K161351NanoBone SBX PuttyArtoss GmbH20161—
+2K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+2K141207Novabone Bioactive StripNovabone Products, LLC20140—
+2K133678Confirm BioactiveGlobus Medical, Inc.20140—
+2K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+2K130392Kinex BioactiveGlobus Medical, Inc.20138—
+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—
+2K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+2K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+2K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+2K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074—
+3K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+3K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+3K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+3K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+3K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+3K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+3K190371Morpheus-CBiogennix, LLC20190—
+3K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbH20190—
+3K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+3K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+3K173008SCS 17-01Anika Therapeutics, Inc.20174—
+3K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+3K163310NovaBone IRMNovabone Products, LLC20170—
+3K160978LITe BIO Delivery SystemStryker Corporation20160—
+3K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+3K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+3K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+3K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+3K132805BG MorselsProsidyan, Inc.201433—
+3K130977Signify BioactiveGlobus Medical, Inc.20131—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+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—
+4K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+4K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+4K223915TactosetAnika Therapeutics, Inc.20231—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+4K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+4K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+4K190956SCS 17-01Anika Therapeutics, Inc.20203—
+4K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+5K250556Porous Biologic ScaffoldVentris Medical20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+5K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+5K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+5K240458Synthetic Bone PuttyVentris Medical20242—
+5K240459Cerament Bone Void FillerBonesupport AB20240—
+5K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+5K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—