510(k) Report

Devices descending from K060061

30 later devices reach Stryker Injectable Cement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173572DSM Biomedical Calcium Phosphate Cement with MicrospheresKensey Nash Corporation Dba Dsm Biomedical20180—
+1K173362DSM Biomedical Calcium Phosphate CementKensey Nash Corporation Dba Dsm Biomedical20183—
+1K161447HydroSet XTOrthovita, Inc.2016102
+1K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+1K071876Cross.BoneTriMed, Inc.20070—
+1K060763Stryker Injectable CementStryker200681
+1K060750Stryker Injectable CementStryker Cmf20060—
+2K241027Permatage Settable Bone PuttyOrthocon, Inc.20242—
+2K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.20240—
+2K231475MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+2K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+2K230054DSM Biomedical Calcium Phosphate CementDsm Biomedical20230—
+2K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+2K221933MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20231—
+2K212991OsteoreviveBone Solutions, Inc.20221—
+2K173008SCS 17-01Anika Therapeutics, Inc.20174—
+2K143661DirectInjectStryker201501
+2K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K261265Permatage XT Settable Bone PuttyOrthocon, Inc.20260—
+3K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.20260—
+3K253854MONTAGE XT Cranial CementOrthocon, Inc.20260—
+3K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+3K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+3K223915TactosetAnika Therapeutics, Inc.20231—
+3K213260CMFlexTMDimension Inx Corp.20220—
+3K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+3K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+3K190956SCS 17-01Anika Therapeutics, Inc.20203—
+4K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—