510(k) Report

Devices descending from K133021

32 later devices reach Mixing Syringe System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141245Etex Mixing and Delivery SystemEtex Corporation201431—
+2K190996Bonus Therapeutics Mixing and Delivery SystemBonus Therapeutics, Ltd.20190—
+2K161447HydroSet XTOrthovita, Inc.2016102
+2K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.201621—
+3K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+3K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+3K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+3K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+3K173008SCS 17-01Anika Therapeutics, Inc.20174—
+3K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+4K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+4K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+4K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+4K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+4K223915TactosetAnika Therapeutics, Inc.20231—
+4K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+4K210997PreferX Delivery SystemMd3, LLC20210—
+4K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+4K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+4K2004313D GraftRasp SystemSurgentec20201—
+4K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+4K190956SCS 17-01Anika Therapeutics, Inc.20203—
+4K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+4K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+4K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+5K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+5K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+5K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+5K2019003D GraftRasp SystemSurgentec20200—
+5K201338Allograft MIS Delivery SystemLifenet Health20202—
+6K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+7K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—