510(k) Report

Devices descending from K051195

140 later devices reach Grafton DBM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180121Rafugen DBMCellumed Co., Ltd.20180—
+1K123691Magnifuse Bone Graft (Cleared as Grafton II Edbm)Medtronic Sofamor Danek, Inc.20135—
+1K103742Accell EVO3 (Formerly Accell A2I)Integra Life Sciences20110—
+1K091321Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc.200922
+1K091193Accell EVO3CIsotis Orthobiologics, Inc.200921
+1K082002Progenix PlusMedtronic Sofamor Danek20080—
+1K081817Accell TBM-RIsotis Orthobiologics, Inc.20080—
+1K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+1K061131DBX-H Hemostatic Demineralized Bone Matrix PuttyOrthocon, Inc.20070—
+1K061668Optecure +CCCExactech, Inc.20062—
+1K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006120—
+2K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+2K212135Dry DBM- A PuttySeaspine Corporation20211—
+2K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+2K172130Resorbable Mesh DeviceSeaSpine Orthopedics Corporation201721
+2K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+2K150621OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc.20150—
+2K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+2K131673Magnifuse Bone Graft, Magifuse II Bone GraftMedtronic Sofamor Danek USA, Inc.20130—
+2K130498Osteoselect Demineralized Bone Matrix PuttyBacterin International, Inc.201311
+2K122868Biosphere Bioactive Bone Graft PuttySynergy Biomedical, LLC20133—
+2K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+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—
+2K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+2K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+2K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+2K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+2K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+2K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC200871—
+2K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+3K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+3K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+3K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+3K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+3K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+3K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+3K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+3K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics Corporation20200—
+3K193040Resorbable Mesh DeviceSeaSpine Orthopedics Corporation20190—
+3K173424BioSphere FlexSynergy Biomedical20180—
+3K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC20180—
+3K163310NovaBone IRMNovabone Products, LLC20170—
+3K160978LITe BIO Delivery SystemStryker Corporation20160—
+3K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+3K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+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—
+3K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+3K132805BG MorselsProsidyan, Inc.201433—
+3K130977Signify BioactiveGlobus Medical, Inc.20131—
+3K130392Kinex BioactiveGlobus Medical, Inc.20138—
+3K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+3K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+3K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+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—
+4K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+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—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K240450Citrepore™Acuitive Technologies, Inc.20240—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+4K190371Morpheus-CBiogennix, LLC20190—
+4K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+4K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+4K173008SCS 17-01Anika Therapeutics, Inc.20174—
+4K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+4K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+4K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+4K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+4K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+4K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+4K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+4K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+4K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+4K090387Kainos+Signus Medizintechnik GmbH20090—
+4K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+5K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+5K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—