510(k) Report

Devices descending from K043261

51 later devices reach Harvest Graft Delivery Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100754Graft Delivery System Model SA-6115Micromedics, Inc.201045—
+1K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+1K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.200637—
+1K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+2K151543Graft Delivery Device with Integrated StyletMicromedics, Inc. (D/B/A Nordson Medical)20150—
+2K121124Arthrex Mixing and Delivery SystemArthrex, Inc.201236—
+2K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC201141—
+2K110787Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15)Orthogem Limited20111—
+3K160978LITe BIO Delivery SystemStryker Corporation20160—
+3K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)Orthogem, Ltd.20150—
+3K142535ConMed Mixing and Delivery KitConmed Corporation20150—
+3K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC)20141—
+3K141245Etex Mixing and Delivery SystemEtex Corporation201431—
+3K133021Mixing Syringe SystemZimmer Knee Creations, Inc.201432—
+3K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC201240—
+4K190996Bonus Therapeutics Mixing and Delivery SystemBonus Therapeutics, Ltd.20190—
+4K161447HydroSet XTOrthovita, Inc.2016102
+4K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.201621—
+4K143488InFill Graft Delivery SystemPinnacle Spine Group, LLC20140—
+4K142661Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC201415—
+5K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC20240—
+5K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+5K231456Avitus® DragonWing Large Volume Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+5K230492Avitus® Precision Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+5K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+5K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+5K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+6K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+6K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+6K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+6K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+6K223915TactosetAnika Therapeutics, Inc.20231—
+6K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+6K210997PreferX Delivery SystemMd3, LLC20210—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+6K2004313D GraftRasp SystemSurgentec20201—
+6K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+6K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+6K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+6K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+7K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+7K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+7K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+7K2019003D GraftRasp SystemSurgentec20200—
+7K201338Allograft MIS Delivery SystemLifenet Health20202—
+8K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+9K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—