510(k) Report

Devices descending from K022629

58 later devices reach WMT-TCP Bone Graft Substitute through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051093Osteopore PCL ScaffoldOsteopore, Inc.200621
+1K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc.20031—
+1K031817Cellplex TCP Synthetic Cancellous BoneWrightmedicaltechnologyinc200352—
+2K251959TnR Cranial ImplantT&R BIOFAB CO., Ltd.20260—
+2K123633TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc.20130—
+2K063346Pro Osteon 500REbi, L.P.20070—
+2K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.2005512
+3K100754Graft Delivery System Model SA-6115Micromedics, Inc.201045—
+3K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+3K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.200637—
+3K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+4K151543Graft Delivery Device with Integrated StyletMicromedics, Inc. (D/B/A Nordson Medical)20150—
+4K121124Arthrex Mixing and Delivery SystemArthrex, Inc.201236—
+4K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC201141—
+4K110787Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15)Orthogem Limited20111—
+5K160978LITe BIO Delivery SystemStryker Corporation20160—
+5K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)Orthogem, Ltd.20150—
+5K142535ConMed Mixing and Delivery KitConmed Corporation20150—
+5K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC)20141—
+5K141245Etex Mixing and Delivery SystemEtex Corporation201431—
+5K133021Mixing Syringe SystemZimmer Knee Creations, Inc.201432—
+5K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC201240—
+6K190996Bonus Therapeutics Mixing and Delivery SystemBonus Therapeutics, Ltd.20190—
+6K161447HydroSet XTOrthovita, Inc.2016102
+6K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.201621—
+6K143488InFill Graft Delivery SystemPinnacle Spine Group, LLC20140—
+6K142661Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC201415—
+7K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC20240—
+7K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+7K231456Avitus® DragonWing Large Volume Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+7K230492Avitus® Precision Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+7K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+7K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+7K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+7K173008SCS 17-01Anika Therapeutics, Inc.20174—
+7K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+8K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+8K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+8K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+8K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+8K223915TactosetAnika Therapeutics, Inc.20231—
+8K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+8K210997PreferX Delivery SystemMd3, LLC20210—
+8K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+8K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+8K2004313D GraftRasp SystemSurgentec20201—
+8K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+8K190956SCS 17-01Anika Therapeutics, Inc.20203—
+8K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+8K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+8K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+9K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+9K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+9K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+9K2019003D GraftRasp SystemSurgentec20200—
+9K201338Allograft MIS Delivery SystemLifenet Health20202—
+10K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+11K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—