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
+1K133678Confirm BioactiveGlobus Medical, Inc.20140—
+1K130977Signify BioactiveGlobus Medical, Inc.20131—
+1K130392Kinex BioactiveGlobus Medical, Inc.20138—
+1K090641CuriosProgentix Orthobiology BV200979—
+1K090387Kainos+Signus Medizintechnik GmbH20090—
+1K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+1K073064Graftys BCPGraftys20082—
+1K061499OsferionOlympus America, Inc.200773—
+1K053228Therigraft TCP Putty Bone Void FillerTherics, LLC200602
+1K051775Osteomimetic Synthetic Bone MatrixBiomimetic Pharmaceuticals, Inc.20050—
+1K050357Camceram TCPCam Implants B.V.20051—
+1K050666Generos, Models GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-Xyz…Berkeley Advanced Biomaterials, Inc.20050—
+1K050025Nanoss Bone Void FillerAngstrom Medica, Inc.200511—
+1K041421Name Bone Void FillerStryker Biotech200441
+1K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc.200454—
+1K040454Biofill Bone Void FillerScient'X20040—
+1K040600Genex Bone Graft SubstituteBiocomposites, Ltd.20040—
+1K032268MBCPBiomatlante2003142—
+1K031826TRIHA +Teknimed, S.A.200321
+1K032130Vitoss-Filled CartridgeOrthovita, Inc.200350—
+1K031817Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc200352—
+1K030131Ossatura BCP Bone Void FillerIsotis NV2003133—
+1K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc.20033—
+1K021963Biosorb Resorbable Void FillerSciences ET Bio Materiaux (Sbm)2003211
+1K014053Conduit TCP GranulesDepuyacromed20027—
+1K012751Healos Bone Graft MaterialOrquest, Inc.200184—
+2K240450Citrepore™Acuitive Technologies, Inc.20240—
+2K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+2K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+2K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+2K191974NuVasive AttraX PuttyNu Vasive, Incorporated201971—
+2K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+2K172237Bicera Resorbable Bone SubstituteWiltrom Corporation Limited20180—
+2K173008SCS 17-01Anika Therapeutics, Inc.20174—
+2K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+2K161859MagnetOsXpand Biotechnology BV201712—
+2K151584AttraX PuttyProgentix Orthobiology BV201576—
+2K141725Bongold Bone Graft MaterialBeijing Allgens Medical Science & Technology Co, L20151—
+2K140913Nuros Bone Graft SubstituteOriental Resources Development Limited20150—
+2K141207Novabone Bioactive StripNovabone Products, LLC20140—
+2K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+2K130953Neotis; Neotis 50Sbm Sciences For Bio Materials20130—
+2K110949Bicera (TM) Resorbable Bone SubstituteWiltrom Corporation Limited20123—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+2K102937Osteophil Beta-TCPCytophil, Inc.20100—
+2K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+2K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+2K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+2K082286BioactysGraftys20091—
+2K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+2K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+2K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+2K080065OsferionOlympus Terumo Biomaterials Corporation20080—
+2K063157Merries K-Phate Bone Graft SubstituteMerries International, Inc.20080—
+2K071876Cross.BoneTriMed, Inc.20070—
+2K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+2K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+2K070794AtlantikMedical Biomat20070—
+2K071237Copios Bone Void Filler Sponge and PasteKensey Nash Corp.20074—
+2K061462BF+ (PH)Ldr Spine USA20060—
+2K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+2K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+2K061022Bio 1-Kit Biosorb Filled CartridgeScience For Biomaterials20060—
+2K051047Colloss E Bone Void FillerOssacur AG20060—
+2K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+2K051774MBCPBiomatlante200660—
+2K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+2K051722Tricos TBaxter Healthcare Corp20053—
+2K050407Ligafix Resorbable Interference Screw, Models 30 and 60Sciences For Bio Materials20057—
+2K051885MBCPBiomatlante200559—
+2K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511—
+2K043005Modification to MBCPBiomatlante2005122—
+2K050490Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea20050—
+2K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.2005512
+2K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.200567—
+2K043172Trugraft BGS Syringe, Model 600-041Osteobiologics, Inc.20050—
+2K040082Pore-SI Bone Graft SubstituteApatech, Ltd.2004113—
+2K033722Apapore Bone Graft SubstituteApatech, Ltd.200413—
+2K040646Straumann GranulesThe Straumann Co.20042—
+2K040669Ceraform Bone Void FillerTeknimed, S.A.20041—
+2K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc.20031—
+3K260364Device 300419 StripGeistlich Pharma AG20260—
+3K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+3K244006FG Bone Graft MFull Golden Biotech Co., Ltd.20250—
+3K241802Device 300397 PuttyGeistlich Pharma AG20241—
+3K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+3K230736MagnetOs PuttyKuros Biosciences B.V20234—
+3K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+3K223915TactosetAnika Therapeutics, Inc.20231—
+3K220337GaiaBone Bioabsorbable Bone GraftCorliber (Shenzhen) Medical Device Co., Ltd.20230—
+3K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+3K213260CMFlexTMDimension Inx Corp.20220—
+3K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+3K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+3K213111MagnetOs granulesKuros Biosciences B.V20227—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+3K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+3K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC20201—