510(k) Report

Devices descending from K010532

29 later devices reach Osteoset BVF Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051951Cerament Bone Void FillerBonesupport AB200510—
+1K051406Osteocure Resorbable Bead KitNexa Orthopedics, Inc.20053—
+1K050025Nanoss Bone Void FillerAngstrom Medica, Inc.200511—
+1K031319Osteo-G Bone Void Filler SystemAspine USA, Inc.20034—
+2K091688A-Grix Resorbable Bone Void FillerAg Digital Technology Corp.20101—
+2K071004Osteocrete Bone Void FillerBone Solutions, Inc.20092—
+2K081558Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CCPioneer Surgical Technology200810—
+2K073316Cerament Bone Void Filler, Model A0210Bonesupport AB20086—
+2K072444Wellgraft PE IGwowei Technology Co., Ltd.20080—
+2K072170Wellgraft PE IIGwowei Technology Co., Ltd.20080—
+3K212991OsteoreviveBone Solutions, Inc.20221—
+3K201535Cerament Bone Void FillerBonesupport AB20203—
+3K132470Solum IV Bone Void FillerSpinesmith Partners, Llp20140—
+3K121453A-Grix TE Resorable Bone Void FillerAg Digital Technology Corp.20130—
+3K091031Pioneer Surgical Nanoss BVF-EPioneer Surgical Technology20097—
+3K090871Cerament Ibone Void Filler High Contrast, Model a 0210-12Bonesupport AB20091—
+3K083449E-Matrix Graft Bone ExtenderPioneer Surgical Technology20090—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+4K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+4K121177Bond ApatiteAugma Biomaterials, Ltd.20130—
+4K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+4K110561Fortross Bone Void FillerPioneer Surgical Technology20114—
+5K223915TactosetAnika Therapeutics, Inc.20231—
+5K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+5K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+6K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K242797OsteoFlo HydroFiberSurGenTec, LLC20241—