510(k) Report

Devices descending from K141245

31 later devices reach Etex Mixing and Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190996Bonus Therapeutics Mixing and Delivery SystemBonus Therapeutics, Ltd.20190—
+1K161447HydroSet XTOrthovita, Inc.2016102
+1K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.201621—
+2K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+2K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+2K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+2K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+2K173008SCS 17-01Anika Therapeutics, Inc.20174—
+2K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+3K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+3K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+3K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+3K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+3K223915TactosetAnika Therapeutics, Inc.20231—
+3K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+3K210997PreferX Delivery SystemMd3, LLC20210—
+3K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+3K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+3K2004313D GraftRasp SystemSurgentec20201—
+3K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+3K190956SCS 17-01Anika Therapeutics, Inc.20203—
+3K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+3K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+3K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+4K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+4K2019003D GraftRasp SystemSurgentec20200—
+4K201338Allograft MIS Delivery SystemLifenet Health20202—
+5K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+6K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—