510(k) Report

Devices descending from K852682

190 later devices reach Calcitite Bone Graft Mat/Oral & Maxillofacial Surg through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K140946Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive CompositeNovabone Products, LLC20146—
+5K130392Kinex BioactiveGlobus Medical, Inc.20138—
+5K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+5K112773Novabne Putty Bioactive Synthetic Bone GraftNovabone Products, LLC201138—
+5K110925Novabone Macropor-SI+ - Bioactive Bone GraftNovabone Products, LLC20110—
+5K110368Novabone Putty - Bioactive Synthetic Bone GraftNovabone Products, LLC201143—
+5K102867Iroot FSInnovative Bioceramix, Inc.20102—
+5K101860Novabone Putty- Bioactive Synthetic Bone GraftNovabone Products, LLC201047—
+5K083783VF LiquigelCoapt Systems, Inc.20090—
+6K262050Vioseal XSpident Co., Ltd.20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+6K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+6K243353One-Fil PuttyMediclus Co., Ltd.20251—
+6K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+6K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.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—
+6K240919Silk Voice (SMI-04)Sofregen Medical20240—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K231716OsteoFlo® HydroPutty™SurGenTec, LLC20230—
+6K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+6K220498NovoGen Wound MatrixNovabone Products, LLC20231—
+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—
+6K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+6K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+6K190371Morpheus-CBiogennix, LLC20190—
+6K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbH20190—
+6K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.20180—
+6K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20183—
+6K173008SCS 17-01Anika Therapeutics, Inc.20174—
+6K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.201730—
+6K163310NovaBone IRMNovabone Products, LLC20170—
+6K160978LITe BIO Delivery SystemStryker Corporation20160—
+6K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+6K151154FIBERGRAFT BG MorselsProsidyan, Inc.201531—
+6K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System…Novabone Products, LLC20150—
+6K143533Fibergraft BG Putty Bone Graft SubstituteProsidyan, Inc.201531—
+6K132805BG MorselsProsidyan, Inc.201433—
+6K130977Signify BioactiveGlobus Medical, Inc.20131—
+7K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…Berkeley Advanced Biomaterials20260—
+7K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+7K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+7K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+7K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+7K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+7K223915TactosetAnika Therapeutics, Inc.20231—
+7K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+7K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.20221—
+7K221737InstaFill Graft Delivery System, SIGNIFY BioactiveGlobus Medical, Inc.20220—
+7K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+7K211905UltraCal XSUltradent Products, Inc.20210—
+7K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+7K212229White Endoseal MTAMaruchi20210—
+7K190956SCS 17-01Anika Therapeutics, Inc.20203—
+8K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—
+8K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+8K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+8K250556Porous Biologic ScaffoldVentris Medical20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+8K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+8K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+8K240458Synthetic Bone PuttyVentris Medical20242—
+8K240459Cerament Bone Void FillerBonesupport AB20240—
+8K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—
+8K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+8K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+9K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K243474MagnetOs MISKuros Biosciences B.V20250—
+9K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+9K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+9K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+10K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+10K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—