510(k) Report

Devices descending from K961511

11 later devices reach Hapset Hydroxylapatite Bone Graft Plaster through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051951Cerament Bone Void FillerBonesupport AB200510—
+2K071004Osteocrete Bone Void FillerBone Solutions, Inc.20092—
+2K073316Cerament Bone Void Filler, Model A0210Bonesupport AB20086—
+3K212991OsteoreviveBone Solutions, Inc.20221—
+3K201535Cerament Bone Void FillerBonesupport AB20203—
+3K090871Cerament Ibone Void Filler High Contrast, Model a 0210-12Bonesupport AB20091—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+4K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+4K121177Bond ApatiteAugma Biomaterials, Ltd.20130—
+5K223915TactosetAnika Therapeutics, Inc.20231—