510(k) Report

Devices descending from K922489

132 later devices reach Medpor Surg Implant Material:Prefor Cran/Fac Impla through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K161447HydroSet XTOrthovita, Inc.2016102
+6K140309CranioplugOssdsign AB20142—
+6K132198Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc.20130—
+6K122156Orthocon Absorbable Hemostatic Bone PuttyOrthocon, Inc.20133—
+6K111524MP 719Marine Polymer Technologies, Inc.20110—
+6K102071Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc.201017—
+6K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+6K071876Cross.BoneTriMed, Inc.20070—
+7K261265Permatage XT Settable Bone PuttyOrthocon, Inc.20260—
+7K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.20260—
+7K253854MONTAGE XT Cranial CementOrthocon, Inc.20260—
+7K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20231—
+7K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+7K230054DSM Biomedical Calcium Phosphate CementDsm Biomedical20230—
+7K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+7K212991OsteoreviveBone Solutions, Inc.20221—
+7K193052HBP6 Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20201—
+7K182742DB-CMFDimensional Bioceramics, LLC20190—
+7K181539OSSDSIGN CranioplugOssdsign AB20181—
+7K173008SCS 17-01Anika Therapeutics, Inc.20174—
+7K140117Ahbppress Absorbable Hemostatic Bone PuttyOrthocon, Inc.20142—
+7K111575Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc.20126—
+8K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+8K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+8K231386Montage Flowable XRO Settable, Resorbable Hemostatic Bone PasteOrthocon, Inc.20230—
+8K223915TactosetAnika Therapeutics, Inc.20231—
+8K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+8K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+8K190956SCS 17-01Anika Therapeutics, Inc.20203—
+8K142339HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC20140—
+8K121953Hemasorb ApplyOrthocon, Inc.20120—
+9K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—