510(k) Report

Devices descending from K011386

188 later devices reach Ebi Osteostim Granules-Resorbable Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+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—
+5K213260CMFlexTMDimension Inx Corp.20220—
+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—
+5K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+5K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+5K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+5K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+5K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+5K130703Vivorte BVFVivorte, Inc.201311
+5K113049Socket GraftSteiner Laboratories20120—
+5K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+5K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+5K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+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—
+5K090387Kainos+Signus Medizintechnik GmbH20090—
+5K082002Progenix PlusMedtronic Sofamor Danek20080—
+5K082463ProgenixMedtronic Sofamor Danek20080—
+5K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+6K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+6K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+6K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+6K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K243474MagnetOs MISKuros Biosciences B.V20250—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+6K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+6K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+6K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+6K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+6K223915TactosetAnika Therapeutics, Inc.20231—
+6K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+6K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+6K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+6K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+6K182107CarriGen PFEtex Corporation20181—
+6K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+6K143547Vivorte Trabexus EBVivorte, Inc.201501
+6K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+6K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+6K102528N-Force Fixation SystemInnovision, Inc.20115—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+7K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+7K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+7K151146N-Force Fixation SystemInnovision, Inc.20151—
+7K142776Flow-ScrewFlow-Fx, LLC20151—
+7K132244N-Force Fixation SystemInnovision, Inc.20143—
+8K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+8K173556Injection ScrewBiedermann Medtech, Inc.20180—