510(k) Report

Devices descending from K032288

123 later devices reach Vitoss Scaffold Foam Bone Graft Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+1K160566Cerasorb Ortho FoamCurasan AG20160—
+1K160446MCP Bone PuttyBiostructures, LLC20161—
+1K141429Sorrento Bone Graft SubstituteHaider Biologics, LLC20152—
+1K142276MCS Bone GraftBiostructures, LLC20153—
+1K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+1K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+1K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+1K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+1K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+1K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+1K063124Integra Mozaik Bone Regeneration Matrix - StripsIntegra Lifesciences Corp.2007401
+1K062353Mozaik Bone Regeneration Matrix - PuttyIntegra LifeSciences Corporation200623
+1K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+1K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+1K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+1K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511—
+2K260364Device 300419 StripGeistlich Pharma AG20260—
+2K241802Device 300397 PuttyGeistlich Pharma AG20241—
+2K240450Citrepore™Acuitive Technologies, Inc.20240—
+2K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+2K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+2K230486Cove StripSeaSpine Orthopedics Corporation20231—
+2K223915TactosetAnika Therapeutics, Inc.20231—
+2K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+2K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+2K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC20201—
+2K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+2K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+2K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+2K173933Sorrento Bioglass Bone Graft SubstituteXenco Medical, LLC20180—
+2K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+2K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials201701
+2K162860MCS Bone GraftBioventus, LLC20170—
+2K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+2K141207Novabone Bioactive StripNovabone Products, LLC20140—
+2K141841Integra Mozaik Osteoconductive Scaffold - StripIntegra Lifescience Corportation20140—
+2K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+2K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+2K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+2K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+2K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+2K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+2K092608Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc.20100—
+2K091302Integra Mozaik and OS Moldable MorselsIntegra LifeSciences Corporation20090—
+2K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+2K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+2K082166Mastergraft StripMedtronic Sofamor Danek200938—
+2K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+2K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+2K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+2K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+3K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+3K251556Device 300423 GranulesGeistlich Pharma AG20250—
+3K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+3K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+3K240765Porous Biologic ScaffoldVentris Medical20240—
+3K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+3K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+3K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation20230—
+3K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+3K213260CMFlexTMDimension Inx Corp.20220—
+3K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+3K221644Synthetic Bone PuttyVentris Medical20220—
+3K212991OsteoreviveBone Solutions, Inc.20221—
+3K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+3K200640Altapore ShapeBaxter Healthcare Corporation20201—
+3K192363AltaporeBaxter Healthcare Corporation20204—
+3K191513Altapore ShapeBaxter Healthcare Corporation20192—
+3K181721Ceracell Ortho FoamCurasan AG20180—
+3K181225AltaporeBaxter Healthcare Corporation20186—
+3K173525NovoGroOsteonovus, Inc.20180—
+3K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+3K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+3K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K141824Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc.20140—
+3K133678Confirm BioactiveGlobus Medical, Inc.20140—
+3K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+3K130703Vivorte BVFVivorte, Inc.201311
+3K130392Kinex BioactiveGlobus Medical, Inc.20138—
+3K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+3K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+3K113049Socket GraftSteiner Laboratories20120—
+3K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+3K093447CarrigenEtex Corp.201021—
+3K090387Kainos+Signus Medizintechnik GmbH20090—
+3K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+3K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+4K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+4K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+4K233259XerosynXerothera, Inc.20240—
+4K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+4K240453ReBOSSISOrthorebirth Co., Ltd.202402
+4K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+4K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+4K201464Altapore MISBaxter Healthcare Corporation20201—