510(k) Report

Devices descending from K030208

121 later devices reach Imbibe II Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081758Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005, 276175010…Depuy Spine, Inc.20080—
+1K072330Controlled Delivery for Osteoplasty (Cdo System) and Graft Preparation SystemBiomet, Inc.200747—
+1K062986Medtronic Graft Delivery SyringeMedtronic Sofamor Danek USA, Inc.200637—
+1K062495Healos FX Bone Graft Substitute and Graft Mixing and Delivery SystemDepuy Spine, Inc.20061—
+1K043172Trugraft BGS Syringe, Model 600-041Osteobiologics, Inc.20050—
+1K041991Aspirex - Bone Marrow Aspirate KitIsotis Orthobiologics, Inc.200473—
+1K032130Vitoss-Filled CartridgeOrthovita, Inc.200350—
+2K151543Graft Delivery Device with Integrated StyletMicromedics, Inc. (D/B/A Nordson Medical)20150—
+2K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC)20141—
+2K141762Perfuse Percutaneous Decompression SystemBiomet, Inc.201401
+2K121124Arthrex Mixing and Delivery SystemArthrex, Inc.201236—
+2K100754Graft Delivery System Model SA-6115Micromedics, Inc.201045—
+2K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+2K062365Arthrex Aspirate KitArthrex, Inc.200637—
+2K061022Bio 1-Kit Biosorb Filled CartridgeScience For Biomaterials20060—
+2K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc.200519—
+2K043261Harvest Graft Delivery SyringeHarvest Technologies, Corp.2005512
+3K240450Citrepore™Acuitive Technologies, Inc.20240—
+3K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+3K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+3K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+3K160978LITe BIO Delivery SystemStryker Corporation20160—
+3K142535ConMed Mixing and Delivery KitConmed Corporation20150—
+3K143546Imbibe Aspirating XIA TapsStryker Corporation20150—
+3K141207Novabone Bioactive StripNovabone Products, LLC20140—
+3K141245Etex Mixing and Delivery SystemEtex Corporation201431—
+3K140868Stryker Kwic NeedleOrthovita, Inc.20141—
+3K140414Imbibe NeedleOrthovita, Inc.201411
+3K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+3K133021Mixing Syringe SystemZimmer Knee Creations, Inc.201432—
+3K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312—
+3K111632Infill Graft Delivery SystemPinnacle Spine Group, LLC201141—
+3K110787Tripore TDD (HA), Tripore TDD (BP90), Tripore TDD (BP15)Orthogem Limited20111—
+3K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+3K103173Vitoss BA Bimodal Bioactive Bone Graft SubstituteOrthovita, Inc.201117—
+3K102545FM-02 Bone Graft SubstituteOrthovita, Inc.20102—
+3K091607Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.200922—
+3K090855Equivabone Osteoinductive Bone Graft SubstituteEtex Corp.200925—
+3K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050—
+4K260572Marrow MarxmanMedimetrix, LLC20260—
+4K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+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—
+4K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+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—
+4K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+4K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+4K161447HydroSet XTOrthovita, Inc.2016102
+4K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc.201621—
+4K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+4K153306Imbibe NeedleOrthovita, Inc.20150—
+4K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)Orthogem, Ltd.20150—
+4K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.20154—
+4K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145—
+4K133678Confirm BioactiveGlobus Medical, Inc.20140—
+4K130703Vivorte BVFVivorte, Inc.201311
+4K130392Kinex BioactiveGlobus Medical, Inc.20138—
+4K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC201240—
+4K113049Socket GraftSteiner Laboratories20120—
+4K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+4K093447CarrigenEtex Corp.201021—
+5K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—
+5K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+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—
+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—
+5K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+5K190814AccuFill Bone Substitute MaterialZimmer Knee Creations20190—
+5K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+5K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+5K182107CarriGen PFEtex Corporation20181—
+5K173008SCS 17-01Anika Therapeutics, Inc.20174—
+5K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+5K143547Vivorte Trabexus EBVivorte, Inc.201501
+5K143488InFill Graft Delivery SystemPinnacle Spine Group, LLC20140—
+5K142661Bi-Portal Bone Graft Delivery DeviceSpinal Surgical Strategies, LLC201415—
+5K130977Signify BioactiveGlobus Medical, Inc.20131—
+5K103799Inqu Paste Mix PlusIsto Technologies, Inc.20119—
+5K102528N-Force Fixation SystemInnovision, Inc.20115—
+5K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+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—
+6K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC20240—
+6K231456Avitus® DragonWing Large Volume Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+6K230492Avitus® Precision Autograft Delivery SystemAvitus Orthopaedics, Inc.20230—
+6K223915TactosetAnika Therapeutics, Inc.20231—
+6K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—