510(k) Report

Devices descending from K990290

50 later devices reach Craniofacial Calcium Phosphate Ceramic Bone Filler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042516OtomimixWalter Lorenz Surgical, Inc.200433—
+1K041089Oss Bone Graft System and Oss Rapidset Bone Graft SystemBiomet Manufacturing, Inc.20040—
+1K023718Quickset Mimix Bone Void FillerWalter Lorenz Surgical, Inc.200243—
+1K021440Bonesource HacStryker Instruments200243—
+1K012569Modification to: Injectable MimixBiomet, Inc.200145—
+2K143661DirectInjectStryker201501
+2K080032Envoycem, Model 1640Envoy Medical Corporation20081—
+2K060750Stryker Injectable CementStryker Cmf20060—
+2K060061Stryker Injectable CementStryker Corp.200630—
+2K032366Bonesource Hac Fast Setting CementStryker Instruments200341—
+2K031435Bonesource BVFHowmedica Osteonics20030—
+3K173572DSM Biomedical Calcium Phosphate Cement with MicrospheresKensey Nash Corporation Dba Dsm Biomedical20180—
+3K173362DSM Biomedical Calcium Phosphate CementKensey Nash Corporation Dba Dsm Biomedical20183—
+3K161447HydroSet XTOrthovita, Inc.2016102
+3K140644ProcemOtotronix, LLC20140—
+3K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+3K071876Cross.BoneTriMed, Inc.20070—
+3K060763Stryker Injectable CementStryker200681
+3K043334Bone Source Hac Rapid Setting CementStryker Instruments200536—
+3K042072Callos CMF Bone Void FillerSkeletal Kinetics, LLC2004310
+4K241027Permatage Settable Bone PuttyOrthocon, Inc.20242—
+4K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.20240—
+4K231475MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+4K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+4K230054DSM Biomedical Calcium Phosphate CementDsm Biomedical20230—
+4K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+4K221933MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20231—
+4K212991OsteoreviveBone Solutions, Inc.20221—
+4K173008SCS 17-01Anika Therapeutics, Inc.20174—
+4K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+4K070012PolyboneKyung Won Medical Co., Ltd.20070—
+4K051603Stryker Injectable CementStryker Leibinger Micro Implants20053—
+4K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC2005213
+5K261265Permatage XT Settable Bone PuttyOrthocon, Inc.20260—
+5K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.20260—
+5K253854MONTAGE XT Cranial CementOrthocon, Inc.20260—
+5K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+5K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+5K223915TactosetAnika Therapeutics, Inc.20231—
+5K213260CMFlexTMDimension Inx Corp.20220—
+5K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+5K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+5K190956SCS 17-01Anika Therapeutics, Inc.20203—
+5K162864OsteoVation ImpactSkeletal Kinetics, LLC201717
+5K140309CranioplugOssdsign AB20142—
+6K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+6K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+6K182742DB-CMFDimensional Bioceramics, LLC20190—
+6K181539OSSDSIGN CranioplugOssdsign AB20181—
+7K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—