510(k) Report

Devices descending from K003339

87 later devices reach Collagen Periodontal Membrane through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102307Genoss Collagen Membrane Model GCM1020, GCM3040 Total 6 ModelsGenoss Co., Ltd.20110—
+1K033729Collagen Dental Wound DressingsCollagen Matrix, Inc.20040—
+1K012751Healos Bone Graft MaterialOrquest, Inc.200184—
+2K141725Bongold Bone Graft MaterialBeijing Allgens Medical Science & Technology Co, L20151—
+2K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+2K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+2K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+2K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+2K051047Colloss E Bone Void FillerOssacur AG20060—
+2K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+2K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+2K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511—
+2K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.200567—
+2K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc.200454—
+3K260364Device 300419 StripGeistlich Pharma AG20260—
+3K241802Device 300397 PuttyGeistlich Pharma AG20241—
+3K223915TactosetAnika Therapeutics, Inc.20231—
+3K220337GaiaBone Bioabsorbable Bone GraftCorliber (Shenzhen) Medical Device Co., Ltd.20230—
+3K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+3K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC20201—
+3K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+3K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials201701
+3K162860MCS Bone GraftBioventus, LLC20170—
+3K160446MCP Bone PuttyBiostructures, LLC20161—
+3K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+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—
+3K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+3K082166Mastergraft StripMedtronic Sofamor Danek200938—
+3K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+3K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+3K071237Copios Bone Void Filler Sponge and PasteKensey Nash Corp.20074—
+3K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+4K251556Device 300423 GranulesGeistlich Pharma AG20250—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K240765Porous Biologic ScaffoldVentris Medical20240—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+4K230486Cove StripSeaSpine Orthopedics Corporation20231—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K221644Synthetic Bone PuttyVentris Medical20220—
+4K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+4K212991OsteoreviveBone Solutions, Inc.20221—
+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—
+4K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+4K181721Ceracell Ortho FoamCurasan AG20180—
+4K181225AltaporeBaxter Healthcare Corporation20186—
+4K173525NovoGroOsteonovus, Inc.20180—
+4K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+4K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+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—
+4K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+4K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+4K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+4K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+4K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+4K072384Modification to Copios Bone Void Filler Sponge & PasteKensey Nash Corp.20070—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K233259XerosynXerothera, Inc.20240—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation20230—
+5K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+5K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+5K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+5K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+5K201464Altapore MISBaxter Healthcare Corporation20201—
+5K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+5K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+5K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+5K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+5K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+5K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+6K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+6K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+6K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+7K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K243474MagnetOs MISKuros Biosciences B.V20250—