510(k) Report

Devices descending from K974399

172 later devices reach Bio-Oss Collagen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122894Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Geistlich Pharma AG201321—
+1K112572Geistlich Combi-Kit CollegenGeistlich Pharma AG201123—
+1K112575Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioGeistlich Pharma AG201111—
+1K090950Bone Plus BCPMegagen Implant Co., Ltd.20101—
+1K092428Bio-Oss CollagenEd. Geistlich Soehne AG Fuer Chemische Industrie201029—
+1K043034Osteoguide Anorganic Bone Mineral ProductsCollagen Matrix, Inc.2005553
+1K042706Ossatura DentalIsotis Orthobiologics, Inc.20046—
+1K040783FoundationTerumo Corp.20043—
+1K031813Ossatura DentalIsotis NV20041—
+1K033679Copsios Bone Void Filler (BVF)Centerpulse Spine-Tech, Inc.200454—
+1K033815Bio-Oss, Bio-Oss Blocks and Bio-Oss CollagenGeistlich-Pharma2004124—
+1K012751Healos Bone Graft MaterialOrquest, Inc.200184—
+2K253723BOSSMedpark Co., Ltd.20260—
+2K242510Geistlich Bio-Flow®Geistlich Pharma AG20250—
+2K240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLC20240—
+2K230305THE Graft CollagenPurgo Biologics, Inc.20240—
+2K240661Geistlich Bio-Oss®Geistlich Pharma AG20242—
+2K231672S1Medpark Co., Ltd.20230—
+2K211551Wishbone HAWishbone SA20210—
+2K202183Porcine Mineral Collagen CompositeCollagen Matrix, Inc.20210—
+2K201546OsOpia Synthetic Bone Void FillerRevisios BV20200—
+2K193212DSM Biomedical Dental Bone Graft PlusDsm Biomedical20200—
+2K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG20199—
+2K173594Straumann ceraboneInstitut Straumann AG20180—
+2K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc.20170—
+2K171643Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedGeistlich Pharma AG201710—
+2K163714Ossix BoneDatum Dental, Ltd.20170—
+2K170541Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.20170—
+2K170245DSM Biomedical Dental Bone GraftKensey Nash Corporation Dba Dsm Biomedical20170—
+2K150079Regenomer® Syringe, Regenomer® Plug, Regenomer® BlockNibec Co., Ltd.20150—
+2K142040Ocs-B CollagenNibec Co., Ltd.20152—
+2K141725Bongold Bone Graft MaterialBeijing Allgens Medical Science & Technology Co, L20151—
+2K140714Porcine Anorganic Bone MineralCollagen Matrix, Inc.201442
+2K123876SynergyOdontit S.A.20140—
+2K113246OCS-BNibec Company, Limited20131—
+2K122240Bone Plus BCP Eagle EyeMegagen Implant Co., Ltd.20120—
+2K120601Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0MM Granules), Geistlich Bio-Oss Pen (0.5 G…Geistlich Pharma AG201216
+2K111087FoundationOlympus Terumo Biomaterials Corporation20110—
+2K103820Reprobone Dental Grafting MaterialCeramisys, Ltd.20110—
+2K111816EquimatrixLuitpold Pharmaceuticals, Inc.20111—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K091424Osta Maxigro and RegigroOsta Technologies20100—
+2K093122MBCP+Biomatlante20100—
+2K090401OrthossEd. Geistlich Soehne AG Fur Chemische Industrie20103—
+2K090850Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteApatech, Ltd.200901
+2K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+2K083742Synoss Collagen Synthetic Mineral-Collagen Bone Graft MatrixCollagen Matrix, Inc.20090—
+2K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+2K081432Healos II Bone Graft SubstituteDepuy Spine, Inc.20083—
+2K080772Bonemedik-DMMeta Biomed Co., Ltd.20080—
+2K073571Tricos T Resorbable Bone SubstituteBaxter Healthcare Corporation20082—
+2K071813Mastergraft PuttyMedtronic Sofamor Danek200747—
+2K072397Synoss Synthetic Bone Graft MaterialCollagen Matrix, Inc.20073—
+2K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+2K071237Copios Bone Void Filler Sponge and PasteKensey Nash Corp.20074—
+2K062200Collagen Matrix Anorganic Bone Mineral Bone Graft MaterialsCollagen Matrix, Inc.20070—
+2K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+2K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+2K051047Colloss E Bone Void FillerOssacur AG20060—
+2K052812Ossimend (TM) Bone Graft MaterialCollagen Matrix, Inc.200640—
+2K051386Mastergraft Putty Bone Void FillerMedtronic Vascular200559—
+2K051443Cerasorb Dental, Cerasorb M Dental and Cerasorb PerioCurasan Ag, Frankfurt Facility200518—
+2K050789Formagraft Collagen Bone Graft MatrixR and D Medical, LLC200511—
+2K043308Modification to: Healos Bone Graft MaterialDepuy Spine, Inc.200567—
+3K254210Rebohil (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)Hyundai Bioland Co., Ltd.20260—
+3K260364Device 300419 StripGeistlich Pharma AG20260—
+3K243745FG Bone Graft BFull Golden Biotech Corporation20250—
+3K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG20250—
+3K251613SwissGraft XGeistlich Pharma AG20250—
+3K241802Device 300397 PuttyGeistlich Pharma AG20241—
+3K230091THE CoverPurgo Biologics, Inc.20230—
+3K223915TactosetAnika Therapeutics, Inc.20231—
+3K221808InterOss CollagenSigmagraft, Inc.20230—
+3K220337GaiaBone Bioabsorbable Bone GraftCorliber (Shenzhen) Medical Device Co., Ltd.20230—
+3K221726Uni-FuZe-C Bone StripZavation Medical Products, LLC20230—
+3K213260CMFlexTMDimension Inx Corp.20220—
+3K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG20223—
+3K210280Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG20213—
+3K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLC20201—
+3K201859Porcine Mineral Collagen Composite MoldableCollagen Matrix, Inc.20200—
+3K192597Cytrans GranulesGC America, Inc.20200—
+3K190754Orthoss (R)Geistlich Pharma AG20190—
+3K173188The Graft Natural Bone SubstitutePurgo Biologics, Inc.20181—
+3K171629ABCcolla Bone GraftAcro Biomedical Co., Ltd.20181—
+3K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+3K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced Biomaterials201701
+3K162860MCS Bone GraftBioventus, LLC20170—
+3K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.20171—
+3K160446MCP Bone PuttyBiostructures, LLC20161—
+3K140021TI-OSSChiyewon20150—
+3K140375Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek USA, Inc.201430—
+3K131385Easy-GraftDegradable Solutions AG20130—
+3K111105Curasan Osseolive DentalCurasan AG20120—
+3K113282Cerasorb Dental,Ceradorb M Dental, Cerasorb PerioRiemser Arzeimittel AG20120—
+3K120152Cerasorb PlusRiemser Arzneimittel AG20120—
+3K120141Kensey Nash Bone Void Filler XCKensey Nash Cororation20120—
+3K110198Blue Sky Bio TCPBlue Sky Bio, LLC20110—
+3K103709Ceracell DentalCurasan AG20111—
+3K091618VitomatrixOrthovita, Inc.20100—
+3K101426Ceros TCP GranulesMathys, Ltd.20100—