510(k) Report

Devices descending from K000122

253 later devices reach Collagraft Strip Bone Graft Matrix (for Use as a Bone Filler), Model 1X,3X,6X… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082166Mastergraft StripMedtronic Sofamor Danek200938—
+1K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+1K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+1K051722Tricos TBaxter Healthcare Corp20053—
+1K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511—
+1K020078Exactech Resorbable Bone PasteExactech, Inc.2004186—
+1K012751Healos Bone Graft MaterialOrquest, Inc.200184—
+2K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+2K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+2K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+2K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+2K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials201701
+2K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+2K141725Bongold Bone Graft MaterialBeijing Allgens Medical Science & Technology Co, L20151—
+2K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+2K132071Bioactive Bone Graft PuttyBiostructures, LLC201461
+2K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+2K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K092608Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc.20100—
+2K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+2K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+2K081717Tricos a Resorbable Bone SubstituteBaxter Healthcare Corp20080—
+2K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+2K081721Tricos a Resorbable SubstituteBaxter Healthcare Corp20080—
+2K080917Iroot SPInnovative Bioceramix, Inc.200837—
+2K073571Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation20082—
+2K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+2K063549Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20072—
+2K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+2K060728Novabone Putty - Bioactive Synthetic GraftNovabone Products, LLC2006120—
+2K051047Colloss E Bone Void FillerOssacur AG20060—
+2K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+2K043209Viagraf DBM PasteOsteotech, Inc.20050—
+2K053098Optium DBM Gel and PuttyLifenet200539—
+2K043048Grafton Plus DBM PasteOsteotech, Inc.20051015
+2K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.200567—
+2K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc.200454—
+2K040755Exactech Resorbable Room Temperature Bone PasteExactech, Inc.200416—
+3K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+3K260364Device 300419 StripGeistlich Pharma AG20260—
+3K252890ZenSeal ProKerr Corporation20260—
+3K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+3K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+3K240765Porous Biologic ScaffoldVentris Medical20240—
+3K242799PliaFX FloLifenet Health20240—
+3K241802Device 300397 PuttyGeistlich Pharma AG20241—
+3K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+3K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLC20241—
+3K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+3K230486Cove StripSeaSpine Orthopedics Corporation20231—
+3K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+3K223915TactosetAnika Therapeutics, Inc.20231—
+3K220337GaiaBone Bioabsorbable Bone GraftCorliber (Shenzhen) Medical Device Co., Ltd.20230—
+3K213260CMFlexTMDimension Inx Corp.20220—
+3K221644Synthetic Bone PuttyVentris Medical20220—
+3K212991OsteoreviveBone Solutions, Inc.20221—
+3K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+3K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont20210—
+3K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC20201—
+3K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+3K200640Altapore ShapeBaxter Healthcare Corporation20201—
+3K192363AltaporeBaxter Healthcare Corporation20204—
+3K191513Altapore ShapeBaxter Healthcare Corporation20192—
+3K190503CeraSealMeta Biomed Co., Ltd.20192—
+3K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+3K181922Sonendo Material ASonendo, Inc.20180—
+3K181721Ceracell Ortho FoamCurasan AG20180—
+3K181225AltaporeBaxter Healthcare Corporation20186—
+3K173525NovoGroOsteonovus, Inc.20180—
+3K170175Endoseal MtaMaruchi20188—
+3K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+3K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+3K171563MagnetOs PuttyKuros Biosciences B.V20174—
+3K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+3K162860MCS Bone GraftBioventus, LLC20170—
+3K160446MCP Bone PuttyBiostructures, LLC20161—
+3K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+3K130312Iroot FMInnovative Bioceramix, Inc.20140—
+3K141824Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc.20140—
+3K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+3K122868Biosphere Bioactive Bone Graft PuttySynergy Biomedical, LLC20133—
+3K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC201138—
+3K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+3K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+3K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+3K102867Iroot FSInnovative Bioceramix, Inc.20102—
+3K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+3K100671Novabone Dental Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC20100—
+3K091484Novabone Dental Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC20091—
+3K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+3K090731Novabone Porous - Synthetic Bone Graft ScaffoldNovabone Products, LLC200910—
+3K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+3K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+3K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+3K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+3K080009Novabone Putty- Bioactive Synthetic GraftNovabone Products, LLC200871—
+3K080329Cap Plus, Equivabone, Cap/DBMEtex Corp.200829—
+3K063050Cap PlusEtex Corp.200734—
+3K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—