510(k) Report

Devices descending from K021440

43 later devices reach Bonesource Hac through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143661DirectInjectStryker201501
+1K032366Bonesource Hac Fast Setting CementStryker Instruments200341—
+1K031435Bonesource BVFHowmedica Osteonics20030—
+2K043334Bone Source Hac Rapid Setting CementStryker Instruments200536—
+2K042072Callos CMF Bone Void FillerSkeletal Kinetics, LLC2004310
+3K070012PolyboneKyung Won Medical Co., Ltd.20070—
+3K060763Stryker Injectable CementStryker200681
+3K060750Stryker Injectable CementStryker Cmf20060—
+3K060061Stryker Injectable CementStryker Corp.200630—
+3K051603Stryker Injectable CementStryker Leibinger Micro Implants20053—
+3K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC2005213
+4K241027Permatage Settable Bone PuttyOrthocon, Inc.20242—
+4K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.20240—
+4K231475MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+4K221933MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20231—
+4K173572DSM Biomedical Calcium Phosphate Cement with MicrospheresKensey Nash Corporation Dba Dsm Biomedical20180—
+4K173362DSM Biomedical Calcium Phosphate CementKensey Nash Corporation Dba Dsm Biomedical20183—
+4K162864OsteoVation ImpactSkeletal Kinetics, LLC201717
+4K161447HydroSet XTOrthovita, Inc.2016102
+4K140309CranioplugOssdsign AB20142—
+4K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+4K071876Cross.BoneTriMed, Inc.20070—
+5K261265Permatage XT Settable Bone PuttyOrthocon, Inc.20260—
+5K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.20260—
+5K253854MONTAGE XT Cranial CementOrthocon, Inc.20260—
+5K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+5K230054DSM Biomedical Calcium Phosphate CementDsm Biomedical20230—
+5K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+5K212991OsteoreviveBone Solutions, Inc.20221—
+5K182742DB-CMFDimensional Bioceramics, LLC20190—
+5K181539OSSDSIGN CranioplugOssdsign AB20181—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+6K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+6K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+6K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+6K223915TactosetAnika Therapeutics, Inc.20231—
+6K213260CMFlexTMDimension Inx Corp.20220—
+6K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+7K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+7K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—