510(k) Report

Devices descending from K963562

383 later devices reach Wright Plaster of Paris Pellets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K082672Novabone Putty-Bioactive Synthetic Bone GraftNovabone Products, LLC200859—
+3K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+3K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+3K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+3K080329Cap Plus, Equivabone, Cap/DBMEtex Corp.200829—
+3K063157Merries K-Phate Bone Graft SubstituteMerries International, Inc.20080—
+3K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+3K063050Cap PlusEtex Corp.200734—
+3K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+3K071937Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20070—
+3K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+3K071121Tribone 80Biomatlante20070—
+3K063527MBCP+Biomatlante200701
+3K070794AtlantikMedical Biomat20070—
+3K070055Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20071—
+3K071237Copios Bone Void Filler Sponge and PasteKensey Nash Corp.20074—
+3K063359INQUIsto Technologies, Inc.200713—
+3K063596Perioglas Putty-Bioactive Bone Graft GelNovabone Products, LLC20074—
+3K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek20069—
+3K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+3K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+3K051047Colloss E Bone Void FillerOssacur AG20060—
+3K050806OptecureExactech, Inc.20063—
+3K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+3K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+3K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511—
+3K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.200567—
+3K040082Pore-SI Bone Graft SubstituteApatech, Ltd.2004113—
+3K033722Apapore Bone Graft SubstituteApatech, Ltd.200413—
+3K040646Straumann GranulesThe Straumann Co.20042—
+3K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc.20033—
+4K262050Vioseal XSpident Co., Ltd.20260—
+4K260364Device 300419 StripGeistlich Pharma AG20260—
+4K253883Bonalive MaxillofacialBonalive, Ltd.20260—
+4K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+4K241802Device 300397 PuttyGeistlich Pharma AG20241—
+4K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+4K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+4K240304Injectable 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—
+4K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+4K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+4K231528Bonalive Orthopedics granulesBonalive Biomaterials, Ltd.20236—
+4K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+4K223915TactosetAnika Therapeutics, Inc.20231—
+4K213757Endocem MTA Premixed RegularMaruchi20230—
+4K220337GaiaBone Bioabsorbable Bone GraftCorliber (Shenzhen) Medical Device Co., Ltd.20230—
+4K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+4K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+4K221811Vista BC SealerInter-Med, Inc.20220—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+4K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+4K213959MagnetOs Flex MatrixKuros Biosciences B.V20220—
+4K213111MagnetOs granulesKuros Biosciences B.V20227—
+4K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+4K202015White ENDOSEAL MTAMaruchi20211—
+4K201799CleaniCalMaruchi20212—
+4K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC20201—
+4K201051Straumann BoneCeramicInstitut Straumann AG20200—
+4K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+4K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+4K191974NuVasive AttraX PuttyNu Vasive, Incorporated201971—
+4K190371Morpheus-CBiogennix, LLC20190—
+4K173424BioSphere FlexSynergy Biomedical20180—
+4K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+4K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+4K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC20180—
+4K170165Osteo-P Bone Graft SubstituteMolecular Matrix, Inc.20170—
+4K173008SCS 17-01Anika Therapeutics, Inc.20174—
+4K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+4K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials201701
+4K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+4K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+4K162860MCS Bone GraftBioventus, LLC20170—
+4K163310NovaBone IRMNovabone Products, LLC20170—
+4K160446MCP Bone PuttyBiostructures, LLC20161—
+4K161351NanoBone SBX PuttyArtoss GmbH20161—
+4K160978LITe BIO Delivery SystemStryker Corporation20160—
+4K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+4K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+4K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+4K151584AttraX PuttyProgentix Orthobiology BV201576—
+4K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+4K132868CarricellEtex Corporation20153—
+4K142104Nanofuse DBMNanotherapeutics, Inc.20151—
+4K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+4K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+4K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+4K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+4K111838Inqu Paste MixIsto Technologies, Inc.20110—
+4K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+4K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+4K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+4K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+4K092608Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc.20100—
+4K093390Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025Depuy Spine, Inc.20100—
+4K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+4K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+4K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+4K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—