510(k) Report

Devices descending from K990131

224 later devices reach Pro Osteon Implant 500R Resorbable Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+3K082286BioactysGraftys20091—
+3K090177Inion Biorestore Biodegradable Bone Graft SubstituteInion OY20092—
+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—
+3K073064Graftys BCPGraftys20082—
+3K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+3K071912Apaceram Bone Graft SubstitutePentax Corp.20071—
+3K072384Modification to Copios Bone Void Filler Sponge & PasteKensey Nash Corp.20070—
+3K071121Tribone 80Biomatlante20070—
+3K063527MBCP+Biomatlante200701
+3K070794AtlantikMedical Biomat20070—
+3K062834Osteon, Models GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050Genoss Co., Ltd.20075—
+3K060732MBCP GelBiomatlante200640—
+3K050806OptecureExactech, Inc.20063—
+4K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+4K251556Device 300423 GranulesGeistlich Pharma AG20250—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K240765Porous Biologic ScaffoldVentris Medical20240—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K230736MagnetOs PuttyKuros Biosciences B.V20234—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+4K230486Cove StripSeaSpine Orthopedics Corporation20231—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K221644Synthetic Bone PuttyVentris Medical20220—
+4K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+4K212991OsteoreviveBone Solutions, Inc.20221—
+4K212156ABCcolla Bone MatrixAcro Biomedical Co., Ltd.20210—
+4K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+4K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+4K200640Altapore ShapeBaxter Healthcare Corporation20201—
+4K192363AltaporeBaxter Healthcare Corporation20204—
+4K191513Altapore ShapeBaxter Healthcare Corporation20192—
+4K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+4K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbH20190—
+4K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+4K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+4K181721Ceracell Ortho FoamCurasan AG20180—
+4K181225AltaporeBaxter Healthcare Corporation20186—
+4K173525NovoGroOsteonovus, Inc.20180—
+4K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+4K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+4K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+4K141824Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc.20140—
+4K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+4K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+4K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+4K122240Bone Plus BCP Eagle EyeMegagen Implant Co., Ltd.20120—
+4K120602Apaceram Bone Graft SubstituteHoya Corporation20120—
+4K112716Osteon IIGenoss Co., Ltd.20121—
+4K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+4K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+4K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+4K102015Osteon, Osteon Sinus, Osteon LiftingGenoss Co., Ltd.20100—
+4K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+4K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+4K080917Iroot SPInnovative Bioceramix, Inc.200837—
+4K061668Optecure +CCCExactech, Inc.20062—
+5K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K251818Bontree PlusHudens Bio Co., Ltd.20260—
+5K252890ZenSeal ProKerr Corporation20260—
+5K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K233259XerosynXerothera, Inc.20240—
+5K240442MagnetOs PuttyKuros Biosciences B.V20243—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation20230—
+5K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+5K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+5K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+5K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+5K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+5K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont20210—
+5K201464Altapore MISBaxter Healthcare Corporation20201—
+5K190503CeraSealMeta Biomed Co., Ltd.20192—
+5K181922Sonendo Material ASonendo, Inc.20180—
+5K170175Endoseal MtaMaruchi20188—
+5K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+5K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+5K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+5K130312Iroot FMInnovative Bioceramix, Inc.20140—
+5K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+5K102867Iroot FSInnovative Bioceramix, Inc.20102—
+5K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+6K262050Vioseal XSpident Co., Ltd.20260—
+6K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K240304Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)Enpuno Biotechnology Co., Ltd.20242—