510(k) Report

Devices descending from K060011

16 later devices reach Miig SR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112383Callos Promodel Bone Void Filler, Skaffold MP (Macro Porous) Bone Void FillerSkeletal Kinetics, LLC201213
+1K070437Pro-Dense Bone Void FillerWrightmedicaltechnologyinc200715—
+2K210193DB-CompositeDimensional Bioceramics, LLC20210—
+2K113871Pro-Dense Bone Graft SubstituteWrightmedicaltechnologyinc201311—
+2K072597Pro-Dense Core Decompression Procedure KitWrightmedicaltechnologyinc200710—
+3K243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty…Orthocon, Inc.20240—
+3K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+3K132656Prodense Bone Graft SubstituteWrightmedicaltechnologyinc20141—
+4K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+4K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+4K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+4K141746AS20 Composite GraftWrightmedicaltechnologyinc20140—
+5K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+5K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+6K223915TactosetAnika Therapeutics, Inc.20231—