510(k) Report

Devices descending from K963562

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K090850Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteApatech, Ltd.200901
+4K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+4K082166Mastergraft StripMedtronic Sofamor Danek200938—
+4K090310EquivaboneEtex Corp.200928—
+4K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+4K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+4K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+4K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+4K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+4K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+4K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+4K071912Apaceram Bone Graft SubstitutePentax Corp.20071—
+4K072384Modification to Copios Bone Void Filler Sponge & PasteKensey Nash Corp.20070—
+4K071428INQUIsto Technologies, Inc.200711—
+4K071206Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd.20071111
+4K061668Optecure +CCCExactech, Inc.20062—
+4K051951Cerament Bone Void FillerBonesupport AB200510—
+4K050170Fortoss Vital Bone Graft SubstituteBiocomposites, Ltd.20050—
+4K050490Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea20050—
+4K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc.20031—
+5K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+5K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+5K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+5K251556Device 300423 GranulesGeistlich Pharma AG20250—
+5K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+5K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+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—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K242782GlassBone GranulesNoraker20240—
+5K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+5K240765Porous Biologic ScaffoldVentris Medical20240—
+5K243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty…Orthocon, Inc.20240—
+5K240450Citrepore™Acuitive Technologies, Inc.20240—
+5K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+5K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+5K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+5K240458Synthetic Bone PuttyVentris Medical20242—
+5K240459Cerament Bone Void FillerBonesupport AB20240—
+5K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+5K230736MagnetOs PuttyKuros Biosciences B.V20234—
+5K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+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—
+5K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation20230—
+5K230486Cove StripSeaSpine Orthopedics Corporation20231—
+5K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+5K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+5K213260CMFlexTMDimension Inx Corp.20220—
+5K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+5K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+5K212991OsteoreviveBone Solutions, Inc.20221—
+5K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+5K211905UltraCal XSUltradent Products, Inc.20210—
+5K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+5K212229White Endoseal MTAMaruchi20210—
+5K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+5K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+5K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+5K200640Altapore ShapeBaxter Healthcare Corporation20201—
+5K190956SCS 17-01Anika Therapeutics, Inc.20203—
+5K192363AltaporeBaxter Healthcare Corporation20204—
+5K191513Altapore ShapeBaxter Healthcare Corporation20192—
+5K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+5K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbH20190—
+5K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+5K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+5K181721Ceracell Ortho FoamCurasan AG20180—
+5K181225AltaporeBaxter Healthcare Corporation20186—
+5K173525NovoGroOsteonovus, Inc.20180—
+5K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+5K170620ReBOSSIS85Orthorebirth Co., Ltd.201702
+5K162087NovoGroOsteonovus, Inc.20170—
+5K1619960.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSEAmend Surgical, Inc.20170—
+5K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+5K141824Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc.20140—
+5K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+5K132377Osteospan MorpheusBiogennix, LLC20144—
+5K130531UltrafuseBaxter Healthcare Corp20147—
+5K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+5K130703Vivorte BVFVivorte, Inc.201311
+5K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+5K120602Apaceram Bone Graft SubstituteHoya Corporation20120—
+5K113049Socket GraftSteiner Laboratories20120—
+5K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+5K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+5K100883CarrigenEtex Corp.20100—
+5K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+5K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+5K093447CarrigenEtex Corp.201021—
+5K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—