510(k) Report

Devices descending from K023088

76 later devices reach Bone Graft Syringe, Model 8600-00X0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC201141—
+1K062173Modification to Bone Graft SyringeWrightmedicaltechnologyinc20060—
+1K060095Modification to: Vaclok SyringeWrightmedicaltechnologyinc20060—
+1K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.2005512
+1K041991Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc.200473—
+2K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC)20141—
+2K133021Mixing Syringe SystemZimmer Knee Creations, Inc.201432—
+2K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC201240—
+2K100754Graft Delivery System Model SA-6115Micromedics, Inc.201045—
+2K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+2K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.200637—
+2K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+2K062365Arthrex Aspirate KitArthrex, Inc.200637—
+2K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc.200519—
+3K160978LITe BIO Delivery SystemStryker Corporation20160—
+3K151543Graft Delivery Device with Integrated StyletMicromedics, Inc. (D/B/A Nordson Medical)20150—
+3K143546Imbibe Aspirating XIA TapsStryker Corporation20150—
+3K143488InFill Graft Delivery SystemPinnacle Spine Group, LLC20140—
+3K142661Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC201415—
+3K141245Etex Mixing and Delivery SystemEtex Corporation201431—
+3K140868Stryker Kwic NeedleOrthovita, Inc.20141—
+3K140414Imbibe NeedleOrthovita, Inc.201411
+3K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312—
+3K121124Arthrex Mixing and Delivery SystemArthrex, Inc.201236—
+3K110787Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15)Orthogem Limited20111—
+3K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+4K260572Marrow MarxmanMedimetrix, LLC20260—
+4K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+4K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+4K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC20240—
+4K231456Avitus® DragonWing Large Volume Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+4K230492Avitus® Precision Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+4K213213Arthrex Vortex Threaded Bone Marrow Recovery NeedleArthrex, Inc.20210—
+4K201743ClarifEye R1.0, ClarifEye NeedlePhilips Medical Systems Nederlands B.V.20210—
+4K190996Bonus Therapeutics Mixing and Delivery SystemBonus Therapeutics, Ltd.20190—
+4K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation20190—
+4K183146Ranfac Cartilage Biopsy NeedleRanfac Corporation20190—
+4K180807Celling Aspiration NeedleSpine Smith Holdings, LLC20180—
+4K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+4K161447HydroSet XTOrthovita, Inc.2016102
+4K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.201621—
+4K153306Imbibe NeedleOrthovita, Inc.20150—
+4K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)Orthogem, Ltd.20150—
+4K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+4K142535ConMed Mixing and Delivery KitConmed Corporation20150—
+4K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+5K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+5K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+5K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+5K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation20231—
+5K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+5K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+5K210997PreferX Delivery SystemMd3, LLC20210—
+5K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+5K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation20201—
+5K2004313D GraftRasp SystemSurgentec20201—
+5K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+5K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+5K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+5K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+6K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+6K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+6K223915TactosetAnika Therapeutics, Inc.20231—
+6K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+6K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+6K2019003D GraftRasp SystemSurgentec20200—
+6K201338Allograft MIS Delivery SystemLifenet Health20202—
+6K190956SCS 17-01Anika Therapeutics, Inc.20203—
+6K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+6K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+7K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+7K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc.20241—
+7K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+7K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20220—
+8K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc.20250—