510(k) Report

Devices descending from K161568

21 later devices reach Bone Solutions Mixing and Delivery System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+1K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+1K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+2K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+2K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+2K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+2K210997PreferX Delivery SystemMd3, LLC20210—
+2K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+2K2004313D GraftRasp SystemSurgentec20201—
+2K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+2K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+2K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+2K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+3K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+3K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+3K2019003D GraftRasp SystemSurgentec20200—
+3K201338Allograft MIS Delivery SystemLifenet Health20202—
+4K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+4K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+4K223915TactosetAnika Therapeutics, Inc.20231—
+5K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—