510(k) Report

Devices descending from K181255

7 later devices reach PRODENSE Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+1K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+1K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+2K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+2K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+3K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+3K223915TactosetAnika Therapeutics, Inc.20231—