510(k) Report

Devices descending from K994337

385 later devices reach Vitoss Scaffold Synthetic Cancellous Bone Void Filler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K201051Straumann BoneCeramicInstitut Straumann AG20200—
+3K190956SCS 17-01Anika Therapeutics, Inc.20203—
+3K171629ABCcolla Bone GraftAcro Biomedical Co., Ltd.20181—
+3K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials201701
+3K171563MagnetOs PuttyKuros Biosciences B.V20174—
+3K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K162860MCS Bone GraftBioventus, LLC20170—
+3K160446MCP Bone PuttyBiostructures, LLC20161—
+3K153676Osteon IiiGenoss Co., Ltd.20160—
+3K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+3K141189Nanobone / GranulateArtoss GmbH20152—
+3K142276MCS Bone GraftBiostructures, LLC20153—
+3K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+3K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+3K132071Bioactive Bone Graft PuttyBiostructures, LLC201461
+3K130703Vivorte BVFVivorte, Inc.201311
+3K122228Ligafix Interference ScrewSbm Sciences For Bio Materials20121—
+3K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+3K113049Socket GraftSteiner Laboratories20120—
+3K103820Reprobone Dental Grafting MaterialCeramisys, Ltd.20110—
+3K100986Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationSkeletal Kinetics, LLC2010011
+3K090950Bone Plus BCPMegagen Implant Co., Ltd.20101—
+3K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+3K100754Graft Delivery System Model SA-6115Micromedics, Inc.201045—
+3K092608Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc.20100—
+3K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+3K093871Periophil B-TCPCytophil, Inc.20100—
+3K093122MBCP+Biomatlante20100—
+3K093447CarrigenEtex Corp.201021—
+3K092788Periophil BiphasicCytophil, Inc.200901
+3K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+3K090850Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteApatech, Ltd.200901
+3K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+3K082166Mastergraft StripMedtronic Sofamor Danek200938—
+3K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+3K090994Ligafix Interface ScrewScience For Biomaterials20092—
+3K082918Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek20091—
+3K082917Mastergraft Resorbable Ceramic GranulesMedtronic Sofamor Danek20093—
+3K081717Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp20080—
+3K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+3K081721Tricos a Resorbable SubstituteBaxter Healthcare Corp20080—
+3K080772Bonemedik-DMMeta Biomed Co., Ltd.20080—
+3K073571Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation20082—
+3K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+3K071912Apaceram Bone Graft SubstitutePentax Corp.20071—
+3K072384Modification to Copios Bone Void Filler Sponge & PasteKensey Nash Corp.20070—
+3K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc.20071—
+3K071206Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd.20071111
+3K062834Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050Genoss Co., Ltd.20075—
+3K063346Pro Osteon 500REbi, L.P.20070—
+3K070507Modification to: Ligafix Interference ScrewScience For Biomaterials200731
+3K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.200637—
+3K061262Ligafix Interference ScrewSciences For Bio Materials20066—
+3K060732MBCP GelBiomatlante200640—
+3K050806OptecureExactech, Inc.20063—
+3K051951Cerament Bone Void FillerBonesupport AB200510—
+3K050170Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd.20050—
+3K042911Cementek LVTeknimed, S.A.20040—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251556Device 300423 GranulesGeistlich Pharma AG20250—
+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—
+4K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+4K240765Porous Biologic ScaffoldVentris Medical20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K232315Catalyst Bone Void FillerOssdsign AB20237—
+4K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+4K230486Cove StripSeaSpine Orthopedics Corporation20231—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K230394Euroscrew NG; Euroscrew TCP NGTeknimed20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221644Synthetic Bone PuttyVentris Medical20220—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—