510(k) Report

Devices descending from K012738

38 later devices reach Symphony Graft Delivery System (GDS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121124Arthrex Mixing and Delivery SystemArthrex, Inc.201236—
+1K062365Arthrex Aspirate KitArthrex, Inc.200637—
+2K160978LITe BIO Delivery SystemStryker Corporation20160—
+2K142535ConMed Mixing and Delivery KitConmed Corporation20150—
+2K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC)20141—
+2K141245Etex Mixing and Delivery SystemEtex Corporation201431—
+2K133021Mixing Syringe SystemZimmer Knee Creations, Inc.201432—
+3K190996Bonus Therapeutics Mixing and Delivery SystemBonus Therapeutics, Ltd.20190—
+3K161447HydroSet XTOrthovita, Inc.2016102
+3K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.201621—
+4K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+4K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+4K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+4K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+4K173008SCS 17-01Anika Therapeutics, Inc.20174—
+4K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+5K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+5K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+5K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+5K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+5K223915TactosetAnika Therapeutics, Inc.20231—
+5K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+5K210997PreferX Delivery SystemMd3, LLC20210—
+5K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+5K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+5K2004313D GraftRasp SystemSurgentec20201—
+5K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+5K190956SCS 17-01Anika Therapeutics, Inc.20203—
+5K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+5K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+5K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+6K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+6K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+6K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+6K2019003D GraftRasp SystemSurgentec20200—
+6K201338Allograft MIS Delivery SystemLifenet Health20202—
+7K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+8K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—