510(k) Report

Devices descending from K994337

385 later devices reach Vitoss Scaffold Synthetic Cancellous Bone Void Filler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K142090RebossisOrthorebirth Co., Ltd.20140—
+5K141600Nanoss Bioactive, Nanoss Bioactive Loaded, and Nanoss Bioactive Loaded KitPioneer Surgical Technology, Inc. (Rti Surgical, I20143—
+5K130312Iroot FMInnovative Bioceramix, Inc.20140—
+5K140710Biomet Graft Delivery SyringesBiomet Spine (Aka Ebi, LLC)20141—
+5K141245Etex Mixing and Delivery SystemEtex Corporation201431—
+5K132244N-Force Fixation SystemInnovision, Inc.20143—
+5K133021Mixing Syringe SystemZimmer Knee Creations, Inc.201432—
+5K121476Infill Graft Delivery SystemPinnacle Spine Group, LLC201240—
+5K102867Iroot FSInnovative Bioceramix, Inc.20102—
+5K090871Cerament Ibone Void Filler High Contrast, Model a 0210-12Bonesupport AB20091—
+5K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+5K082002Progenix PlusMedtronic Sofamor Danek20080—
+5K080462Progenix DBM PuttyMedtronic Sofamor Danek20082—
+6K262050Vioseal XSpident Co., Ltd.20260—
+6K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+6K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+6K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+6K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+6K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250346BonVie+Elute, Inc.20250—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+6K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K240304Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)Enpuno Biotechnology Co., Ltd.20242—
+6K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+6K213757Endocem MTA Premixed RegularMaruchi20230—
+6K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+6K221811Vista BC SealerInter-Med, Inc.20220—
+6K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+6K202015White ENDOSEAL MTAMaruchi20211—
+6K201799CleaniCalMaruchi20212—
+6K193487Agilon StripBiogennix, LLC20200—
+6K193168Agilon MoldableBiogennix, LLC20200—
+6K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+6K190996Bonus Therapeutics Mixing and Delivery SystemBonus Therapeutics, Ltd.20190—
+6K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+6K173556Injection ScrewBiedermann Medtech, Inc.20180—
+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—
+6K121177Bond ApatiteAugma Biomaterials, Ltd.20130—
+6K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+6K082463ProgenixMedtronic Sofamor Danek20080—
+6K081950Progenix PlusMedtronic Sofamor Danek, Inc.20081—
+7K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+7K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+7K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+7K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+7K243353One-Fil PuttyMediclus Co., Ltd.20251—
+7K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC20240—
+7K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+7K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+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—
+7K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+7K211905UltraCal XSUltradent Products, Inc.20210—
+7K212229White Endoseal MTAMaruchi20210—
+7K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+7K192674Mixing and Delivery SystemBone Solutions, Inc.20200—
+7K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20187—
+7K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC201711—
+8K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+8K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC20260—
+8K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+8K243580GraftGun Universal Graft Delivery System (GDS)SurGenTec, LLC20251—
+8K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+8K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+8K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+8K210997PreferX Delivery SystemMd3, LLC20210—
+8K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyinc20201—
+8K2004313D GraftRasp SystemSurgentec20201—
+8K200606O-Genesis Graft Delivery SystemOrthofix, Inc.20200—
+8K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyinc20192—
+8K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyinc20185—
+8K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC20186—
+9K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+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—