510(k) Report

Devices descending from K071206

111 later devices reach Actifuse Abx E-Z-Fil Putty Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193075Osteo3 ZP PuttySirakoss, Ltd.20204—
+1K170620ReBOSSIS85Orthorebirth Co., Ltd.201702
+1K162087NovoGroOsteonovus, Inc.20170—
+1K161351NanoBone SBX PuttyArtoss GmbH20161—
+1K132377Osteospan MorpheusBiogennix, LLC20144—
+1K130531UltrafuseBaxter Healthcare Corp20147—
+1K132071Bioactive Bone Graft PuttyBiostructures, LLC201461
+1K090850Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteApatech, Ltd.200901
+1K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+1K082073Actifuse Flow Bone Graft SubstituteApatech, Ltd.20084—
+1K080736Actifuse Shape Bone Graft SubstituteApatech, Ltd.200879—
+1K072265Progenix DMB PuttyMedtronic Sofamor Danek20084—
+2K221644Synthetic Bone PuttyVentris Medical20220—
+2K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+2K191974NuVasive AttraX PuttyNu Vasive, Incorporated201971—
+2K190371Morpheus-CBiogennix, LLC20190—
+2K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbH20190—
+2K181225AltaporeBaxter Healthcare Corporation20186—
+2K181306Actifuse FlowBaxter Healthcare Corporation20180—
+2K180853EP Granules™ BVFElute, Inc.20181—
+2K171563MagnetOs PuttyKuros Biosciences B.V20174—
+2K151584AttraX PuttyProgentix Orthobiology BV201576—
+2K142828osteoSPAN MorpheusBiogennix20152—
+2K142090RebossisOrthorebirth Co., Ltd.20140—
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+2K082002Progenix PlusMedtronic Sofamor Danek20080—
+2K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+3K250346BonVie+Elute, Inc.20250—
+3K230736MagnetOs PuttyKuros Biosciences B.V20234—
+3K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+3K213260CMFlexTMDimension Inx Corp.20220—
+3K213111MagnetOs granulesKuros Biosciences B.V20227—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+3K193487Agilon StripBiogennix, LLC20200—
+3K193168Agilon MoldableBiogennix, LLC20200—
+3K192363AltaporeBaxter Healthcare Corporation20204—
+3K191513Altapore ShapeBaxter Healthcare Corporation20192—
+3K172497NuVasive AttraX ScaffoldNu Vasive, Incorporated20171—
+3K082463ProgenixMedtronic Sofamor Danek20080—
+3K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+4K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+4K233259XerosynXerothera, Inc.20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K232315Catalyst Bone Void FillerOssdsign AB20237—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K223915TactosetAnika Therapeutics, Inc.20231—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K201464Altapore MISBaxter Healthcare Corporation20201—
+4K200640Altapore ShapeBaxter Healthcare Corporation20201—
+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—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+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—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K240453ReBOSSISOrthorebirth Co., Ltd.202402
+5K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+5K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+5K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+5K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—