510(k) Report

Devices descending from K062459

56 later devices reach Origen DBM with Bioactive Glass through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120279Nanofuse DBMNanotherapeutics20122—
+1K110976Origen DBM with Bioactive Glass, Nanofuse DBMNanotherapeutics, Inc.201132
+1K072184Vitoss Bioactive Foam Bone Graft SubstituteOrthovita, Inc.200751—
+2K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+2K142104Nanofuse DBMNanotherapeutics, Inc.20151—
+2K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+2K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+2K081439Vitoss Bioactive Foam Pack Bone Graft SubstituteOrthovita, Inc.200850—
+3K240450Citrepore™Acuitive Technologies, Inc.20240—
+3K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+3K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+3K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+3K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+3K1619960.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSEAmend Surgical, Inc.20170—
+3K141207Novabone Bioactive StripNovabone Products, LLC20140—
+3K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+3K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+3K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+3K090387Kainos+Signus Medizintechnik GmbH20090—
+3K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+4K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+4K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+4K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+4K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+4K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+4K133678Confirm BioactiveGlobus Medical, Inc.20140—
+4K130703Vivorte BVFVivorte, Inc.201311
+4K130392Kinex BioactiveGlobus Medical, Inc.20138—
+4K113049Socket GraftSteiner Laboratories20120—
+4K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+4K093447CarrigenEtex Corp.201021—
+5K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+5K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+5K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+5K182107CarriGen PFEtex Corporation20181—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K143547Vivorte Trabexus EBVivorte, Inc.201501
+5K130977Signify BioactiveGlobus Medical, Inc.20131—
+5K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+5K102528N-Force Fixation SystemInnovision, Inc.20115—
+5K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+6K223915TactosetAnika Therapeutics, Inc.20231—
+6K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+6K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+6K151146N-Force Fixation SystemInnovision, Inc.20151—
+6K142776Flow-ScrewFlow-Fx, LLC20151—
+6K132244N-Force Fixation SystemInnovision, Inc.20143—
+7K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+7K173556Injection ScrewBiedermann Medtech, Inc.20180—