510(k) Report

Devices descending from K011897

35 later devices reach Norian SRS Bone Void Filler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130703Vivorte BVFVivorte, Inc.201311
+1K131133Vivorte BVF LiteVivorte, Inc.20131—
+1K071004Osteocrete Bone Void FillerBone Solutions, Inc.20092—
+1K082498Graftys HBSGraftys20092—
+1K070220Osteofix Bone Void FillerCalcitec, Inc.20070—
+1K060408Norian SRS Bone Void FillerSynthes (Usa)200601
+1K041089Oss Bone Graft System and Oss Rapidset Bone Graft SystemBiomet Manufacturing, Inc.20040—
+1K041842Norian SRS Fast Set PuttySynthes (Usa)200410—
+1K033611Calcigen -Nap Bone Void FillerBiomet, Inc.20040—
+1K031435Bonesource BVFHowmedica Osteonics20030—
+1K030554CallosSkeletal Kinetics, LLC200311—
+2K212991OsteoreviveBone Solutions, Inc.20221—
+2K143547Vivorte Trabexus EBVivorte, Inc.201501
+2K143549Vivorte TrabexusVivorte, Inc.20150—
+2K100986Callos Bone Void Filler, Skaffold Next Generation Bone Void Filler, Osteo VationSkeletal Kinetics, LLC2010011
+2K093343Grafty QuicksetGraftys20101—
+2K073303Norian DrillableSynthes (Usa)200813
+2K060406Norian SRS Fast Set PuttySynthes (Usa)20060—
+2K051603Stryker Injectable CementStryker Leibinger Micro Implants20053—
+2K051123Callos Impact and Inject Bone Void FillerSkeletal Kinetics, LLC2005917
+2K042072Callos CMF Bone Void FillerSkeletal Kinetics, LLC2004310
+3K231714Graftys QuicksetGraftys20230—
+3K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+3K200752DB-OrthopedicsDimensional Bioceramics, LLC20200—
+3K140309CranioplugOssdsign AB20142—
+3K132211Skaffold NMX Bone Void FillerSkeletal Kinetics, LLC20141—
+3K112383Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSkeletal Kinetics, LLC201213
+3K102722Norian Drillable Inject, Norian Drillable Fast Set PuttySynthes USA Products, LLC201104
+3K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC2005213
+4K212353DB-EZ Bone Void FillerDimensional Bioceramics, LLC20210—
+4K210193DB-CompositeDimensional Bioceramics, LLC20210—
+4K181539OSSDSIGN CranioplugOssdsign AB20181—
+4K162864OsteoVation ImpactSkeletal Kinetics, LLC201717
+5K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+5K182742DB-CMFDimensional Bioceramics, LLC20190—