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
+4K203335MectaScrew ExtensionMedacta International S.A.20220—
+4K212991OsteoreviveBone Solutions, Inc.20221—
+4K212156ABCcolla Bone MatrixAcro Biomedical Co., Ltd.20210—
+4K193513SIGNAFUSE Bioactive Bone GraftBioventus20200—
+4K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+4K200640Altapore ShapeBaxter Healthcare Corporation20201—
+4K192363AltaporeBaxter Healthcare Corporation20204—
+4K191513Altapore ShapeBaxter Healthcare Corporation20192—
+4K191074Sorrento Bone Graft SubstituteXenco Medical, LLC20190—
+4K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+4K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+4K181721Ceracell Ortho FoamCurasan AG20180—
+4K182107CarriGen PFEtex Corporation20181—
+4K181225AltaporeBaxter Healthcare Corporation20186—
+4K173525NovoGroOsteonovus, Inc.20180—
+4K172573ReBOSSIS85Orthorebirth Co., Ltd.201712
+4K170620ReBOSSIS85Orthorebirth Co., Ltd.201702
+4K162087NovoGroOsteonovus, Inc.20170—
+4K161351NanoBone SBX PuttyArtoss GmbH20161—
+4K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.20150—
+4K151543Graft Delivery Device with Integrated StyletMicromedics, Inc. (D/B/A Nordson Medical)20150—
+4K143547Vivorte Trabexus EBVivorte, Inc.201501
+4K141824Mastergraft Matrix Ext; Mastergraft Putty, Mastergraft StripMedtronic Sofamor Danek, Inc.20140—
+4K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+4K132377Osteospan MorpheusBiogennix, LLC20144—
+4K130531UltrafuseBaxter Healthcare Corp20147—
+4K130335Mastergraft Strip; Mastergraft UltramatrixMedtronic Sofamor Danek USA, Inc.20132—
+4K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc.20121—
+4K122240Bone Plus BCP Eagle EyeMegagen Implant Co., Ltd.20120—
+4K121124Arthrex Mixing and Delivery SystemArthrex, Inc.201236—
+4K120602Apaceram Bone Graft SubstituteHoya Corporation20120—
+4K112716Osteon IIGenoss Co., Ltd.20121—
+4K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+4K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+4K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC201141—
+4K102528N-Force Fixation SystemInnovision, Inc.20115—
+4K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+4K110787Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15)Orthogem Limited20111—
+4K102392Microfuse Putty and Microfuse ST MisGlobus Medical, Inc.201001
+4K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+4K102015Osteon, Osteon Sinus, Osteon LiftingGenoss Co., Ltd.20100—
+4K092087Medtronic Dental TCPMedtronic Sofamor Danek USA, Inc.20090—
+4K071004Osteocrete Bone Void FillerBone Solutions, Inc.20092—
+4K083232Modification to:Microfuse Bone Void FillerGlobus Medical, Inc.20081—
+4K082442Modification to Microfuse Bone Void FillerGlobus Medical, Inc.20082—
+4K082073Actifuse Flow Bone Graft SubstituteApatech, Ltd.20084—
+4K073316Cerament Bone Void Filler, Model A0210Bonesupport AB20086—
+4K080736Actifuse Shape Bone Graft SubstituteApatech, Ltd.200879—
+4K080917Iroot SPInnovative Bioceramix, Inc.200837—
+4K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+4K061668Optecure +CCCExactech, Inc.20062—
+5K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K251818Bontree PlusHudens Bio Co., Ltd.20260—
+5K252890ZenSeal ProKerr Corporation20260—
+5K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243474MagnetOs MISKuros Biosciences B.V20250—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.20250—
+5K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+5K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+5K233259XerosynXerothera, Inc.20240—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics Corporation20230—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+5K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+5K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+5K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+5K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont20210—
+5K201535Cerament Bone Void FillerBonesupport AB20203—
+5K201464Altapore MISBaxter Healthcare Corporation20201—
+5K190371Morpheus-CBiogennix, LLC20190—
+5K190503CeraSealMeta Biomed Co., Ltd.20192—
+5K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbH20190—
+5K181922Sonendo Material ASonendo, Inc.20180—
+5K181306Actifuse FlowBaxter Healthcare Corporation20180—
+5K180853EP Granules™ BVFElute, Inc.20181—
+5K170175Endoseal MtaMaruchi20188—
+5K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+5K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+5K160978LITe BIO Delivery SystemStryker Corporation20160—
+5K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)Orthogem, Ltd.20150—
+5K151146N-Force Fixation SystemInnovision, Inc.20151—
+5K142535ConMed Mixing and Delivery KitConmed Corporation20150—
+5K142776Flow-ScrewFlow-Fx, LLC20151—
+5K142828osteoSPAN MorpheusBiogennix20152—