510(k) Report

Devices descending from K082575

56 later devices reach Actifuse Bone Graft Substitute and Abx E-Z-Fil and Shape Bone Graft Substitutes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+1K213111MagnetOs granulesKuros Biosciences B.V20227—
+1K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+1K202639si-MochiBiostone, Ltd.20210—
+1K201464Altapore MISBaxter Healthcare Corporation20201—
+1K181958MagnetOs PuttyKuros Biosciences B.V201810—
+1K141189Nanobone / GranulateArtoss GmbH20152—
+1K130531UltrafuseBaxter Healthcare Corp20147—
+1K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+1K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+1K090850Actifuse Bone Graft Substitute, Actifuse Microgranules Bone Graft SubstituteApatech, Ltd.200901
+2K230736MagnetOs PuttyKuros Biosciences B.V20234—
+2K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+2K223915TactosetAnika Therapeutics, Inc.20231—
+2K181225AltaporeBaxter Healthcare Corporation20186—
+2K161351NanoBone SBX PuttyArtoss GmbH20161—
+2K130703Vivorte BVFVivorte, Inc.201311
+2K113049Socket GraftSteiner Laboratories20120—
+2K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+2K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+2K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+2K093447CarrigenEtex Corp.201021—
+3K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+3K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+3K240442MagnetOs PuttyKuros Biosciences B.V20243—
+3K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+3K192363AltaporeBaxter Healthcare Corporation20204—
+3K191513Altapore ShapeBaxter Healthcare Corporation20192—
+3K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+3K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbH20190—
+3K182107CarriGen PFEtex Corporation20181—
+3K143547Vivorte Trabexus EBVivorte, Inc.201501
+3K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+3K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+3K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+3K102528N-Force Fixation SystemInnovision, Inc.20115—
+3K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+4K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+4K243474MagnetOs MISKuros Biosciences B.V20250—
+4K233259XerosynXerothera, Inc.20240—
+4K200640Altapore ShapeBaxter Healthcare Corporation20201—
+4K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+4K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+4K151146N-Force Fixation SystemInnovision, Inc.20151—
+4K142776Flow-ScrewFlow-Fx, LLC20151—
+4K132244N-Force Fixation SystemInnovision, Inc.20143—
+4K130392Kinex BioactiveGlobus Medical, Inc.20138—
+5K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K173556Injection ScrewBiedermann Medtech, Inc.20180—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K133678Confirm BioactiveGlobus Medical, Inc.20140—
+5K130977Signify BioactiveGlobus Medical, Inc.20131—
+6K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—