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
+3K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd.20070—
+3K071237Copios Bone Void Filler Sponge and PasteKensey Nash Corp.20074—
+3K060794Progenix DBM Putty and PasteMedtronic Sofamor Danek20069—
+3K060917Kensey Nash Bone Void FillerKensey Nash Corporation20067—
+3K050806OptecureExactech, Inc.20063—
+4K262050Vioseal XSpident Co., Ltd.20260—
+4K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+4K251556Device 300423 GranulesGeistlich Pharma AG20250—
+4K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+4K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+4K233259XerosynXerothera, Inc.20240—
+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—
+4K240453ReBOSSISOrthorebirth Co., Ltd.202402
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+4K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation20230—
+4K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+4K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+4K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+4K213757Endocem MTA Premixed RegularMaruchi20230—
+4K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+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—
+4K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+4K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+4K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+4K202015White ENDOSEAL MTAMaruchi20211—
+4K201799CleaniCalMaruchi20212—
+4K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLC20201—
+4K201464Altapore MISBaxter Healthcare Corporation20201—
+4K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+4K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+4K173424BioSphere FlexSynergy Biomedical20180—
+4K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+4K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLC20180—
+4K163310NovaBone IRMNovabone Products, LLC20170—
+4K160978LITe BIO Delivery SystemStryker Corporation20160—
+4K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+4K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+4K132868CarricellEtex Corporation20153—
+4K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+4K141207Novabone Bioactive StripNovabone Products, LLC20140—
+4K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+4K133678Confirm BioactiveGlobus Medical, Inc.20140—
+4K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+4K140844Biosphere Bioactive Bone Graft Putty, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc.20141—
+4K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+4K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+4K132805BG MorselsProsidyan, Inc.201433—
+4K130977Signify BioactiveGlobus Medical, Inc.20131—
+4K130392Kinex BioactiveGlobus Medical, Inc.20138—
+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—
+4K112428Novabone Dental Morsels - Bioactive Synthetic Bone GraftNovabone Products, LLC20110—
+4K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+4K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+4K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+4K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+4K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+4K090310EquivaboneEtex Corp.200928—
+4K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+4K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+4K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+4K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+4K071187Microfuse Bone Void FillerGlobus Medical, Inc.20074—
+4K072384Modification to Copios Bone Void Filler Sponge & PasteKensey Nash Corp.20070—
+4K061668Optecure +CCCExactech, Inc.20062—
+5K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+5K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+5K250556Porous Biologic ScaffoldVentris Medical20250—
+5K243353One-Fil PuttyMediclus Co., Ltd.20251—
+5K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+5K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+5K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+5K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+5K240450Citrepore™Acuitive Technologies, Inc.20240—
+5K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+5K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+5K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K240458Synthetic Bone PuttyVentris Medical20242—
+5K240459Cerament Bone Void FillerBonesupport AB20240—
+5K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+5K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+5K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+5K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+5K211905UltraCal XSUltradent Products, Inc.20210—
+5K212229White Endoseal MTAMaruchi20210—
+5K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+5K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+5K190371Morpheus-CBiogennix, LLC20190—