510(k) Report

Devices descending from K060728

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+1K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+1K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+1K122868Biosphere Bioactive Bone Graft PuttySynergy Biomedical, LLC20133—
+1K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC201138—
+1K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+1K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+1K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+1K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+1K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+1K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+1K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC200871—
+1K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+1K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+2K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+2K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+2K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+2K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+2K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+2K173424BioSphere FlexSynergy Biomedical20180—
+2K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC20180—
+2K163310NovaBone IRMNovabone Products, LLC20170—
+2K160978LITe BIO Delivery SystemStryker Corporation20160—
+2K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+2K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+2K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+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—
+2K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+2K132805BG MorselsProsidyan, Inc.201433—
+2K130977Signify BioactiveGlobus Medical, Inc.20131—
+2K130392Kinex BioactiveGlobus Medical, Inc.20138—
+2K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+2K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+2K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+2K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+2K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+2K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+2K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+2K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+3K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+3K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+3K250556Porous Biologic ScaffoldVentris Medical20250—
+3K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+3K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+3K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+3K240450Citrepore™Acuitive Technologies, Inc.20240—
+3K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+3K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+3K240458Synthetic Bone PuttyVentris Medical20242—
+3K240459Cerament Bone Void FillerBonesupport AB20240—
+3K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+3K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+3K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+3K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+3K190371Morpheus-CBiogennix, LLC20190—
+3K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+3K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+3K173008SCS 17-01Anika Therapeutics, Inc.20174—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+3K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+3K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+3K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+3K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+3K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+3K090387Kainos+Signus Medizintechnik GmbH20090—
+3K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+4K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+4K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+4K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K243474MagnetOs MISKuros Biosciences B.V20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K223915TactosetAnika Therapeutics, Inc.20231—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+4K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+4K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+4K190956SCS 17-01Anika Therapeutics, Inc.20203—
+4K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+4K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+4K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K130703Vivorte BVFVivorte, Inc.201311
+4K113049Socket GraftSteiner Laboratories20120—