510(k) Report

Devices descending from K012589

17 later devices reach Fast Set Putty through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102018Norian Reinforced, Norian Reinforced Fast Set PuttySynthes USA Products, LLC20100—
+1K060443Norian CRS Fast Set PuttySynthes (Usa)20060—
+1K042072Callos CMF Bone Void FillerSkeletal Kinetics, LLC2004310
+1K041842Norian SRS Fast Set PuttySynthes (Usa)200410—
+2K071004Osteocrete Bone Void FillerBone Solutions, Inc.20092—
+2K073303Norian DrillableSynthes (Usa)200813
+2K060406Norian SRS Fast Set PuttySynthes (Usa)20060—
+2K051603Stryker Injectable CementStryker Leibinger Micro Implants20053—
+2K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC2005213
+3K212991OsteoreviveBone Solutions, Inc.20221—
+3K162864OsteoVation ImpactSkeletal Kinetics, LLC201717
+3K140309CranioplugOssdsign AB20142—
+3K102722Norian Drillable Inject, Norian Drillable Fast Set PuttySynthes USA Products, LLC201104
+4K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+4K182742DB-CMFDimensional Bioceramics, LLC20190—
+4K181539OSSDSIGN CranioplugOssdsign AB20181—
+5K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—