Orthopedic

MQV · Filler, Bone Void, Calcium Compound

Orthopedic · 21 CFR 888.3045 · Class 2

Overview

Product CodeMQV
Device NameFiller, Bone Void, Calcium Compound
Regulation21 CFR 888.3045
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

Classification Rationale

Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.

Cleared Devices (489)

RecordDevice NameApplicantDecision DateDecision
K253524Adaptos®Fuse Bone GraftBiomendex OYFeb 17, 2026SESE
K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteProsidyan, Inc.Oct 22, 2025SESE
K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.Oct 13, 2025SESE
K252085Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)Wright Medical Technology, Inc. (Stryker Corporation)Sep 30, 2025SESE
K251556Device 300423 GranulesGeistlich Pharma AGJul 17, 2025SESE
K251720OsteoFlo HydroFiberSurGenTec, LLCJul 2, 2025SESE
K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftMedtronic Sofamor Danek, Inc.Jun 12, 2025SESE
K243949OsteoFlo HydroFiberSurGenTec, LLCMay 28, 2025SESE
K243474MagnetOs MISKuros Biosciences B.VMay 23, 2025SESE
K250141Synthecure Synthetic Calcium SulfateAustin Medical Ventures, Inc.May 16, 2025SESE
K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.Apr 7, 2025SESE
K250556Porous Biologic ScaffoldVentris MedicalMar 21, 2025SESE
K250346BonVie+Elute, Inc.Feb 26, 2025SESE
K241555Moldable Bone Void Filler and Moldable Bone Void Filler + CCCRti Surgical, Inc.Feb 21, 2025SESE
K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.Jan 17, 2025SESE
K242797OsteoFlo HydroFiberSurGenTec, LLCDec 23, 2024SESE
K242782GlassBone GranulesNorakerDec 23, 2024SESE
K241167BioSphere Putty; BioSphere MIS PuttySynergy BiomedicalDec 20, 2024SESE
K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex CorporationDec 18, 2024SESE
K240765Porous Biologic ScaffoldVentris MedicalDec 18, 2024SESE
K243526MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.Dec 5, 2024SESE
K243506Montage-XT Settable Bone PuttyOrthocon, Inc.Nov 18, 2024SESE
K241802Device 300397 PuttyGeistlich Pharma AGNov 8, 2024SESE
K240450Citrepore™Acuitive Technologies, Inc.Nov 6, 2024SESE
K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.Oct 18, 2024SESE
K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLCSep 25, 2024SESE
K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics CorporationSep 25, 2024SESE
K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous ChipsStryker SpineAug 29, 2024SESE
K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.Aug 21, 2024SESE
K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare CorporationAug 2, 2024SESE
K242050Montage Settable Bone PuttyOrthocon, Inc.Jul 29, 2024SESE
K241212MagnetOs Easypack PuttyKuros BiosciencesJun 27, 2024SESE
K233259XerosynXerothera, Inc.Jun 21, 2024SESE
K240621Morpheus® Moldable; Agilon® MoldableBiogennix, LLCApr 30, 2024SESE
K240442MagnetOs PuttyKuros Biosciences B.VApr 1, 2024SESE
K240507NuVasive AttraX ScaffoldNuvasive, Inc.Mar 20, 2024SESE
K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.Mar 12, 2024SESE
K240458Synthetic Bone PuttyVentris MedicalMar 7, 2024SESE
K240459Cerament Bone Void FillerBonesupport ABMar 5, 2024SESE
K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)Novabone Products, LLCMar 5, 2024SESE
K240453ReBOSSISOrthorebirth Co., Ltd.Mar 4, 2024SESE
K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.Feb 5, 2024SESE
K232347MagnetOs GranulesKuros Biosciences B.VJan 19, 2024SESE
K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.Dec 20, 2023SESE
K230736MagnetOs PuttyKuros Biosciences B.VDec 20, 2023SESE
K233607MagnetOs Easypack PuttyKuros Biosciences B.VDec 15, 2023SESE
K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLCDec 5, 2023SESE
K233245MagnetOs Flex MatrixKuros Biosciences B.VNov 21, 2023SESE
K231716OsteoFlo® HydroPutty™SurGenTec, LLCOct 2, 2023SESE
K232668Cove Strip, OsteoCove StripSeaSpine Orthopedics CorporationSep 27, 2023SESE
K232315Catalyst Bone Void FillerOssdsign ABSep 15, 2023SESE
K231030Cove Putty, OsteoCove PuttySeaSpine Orthopedics CorporationSep 14, 2023SESE
K231270Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.Sep 1, 2023SESE
K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.Aug 25, 2023SESE
K230486Cove StripSeaSpine Orthopedics CorporationAug 21, 2023SESE
K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.Aug 2, 2023SESE
K231714Graftys QuicksetGraftysJul 12, 2023SESE
K231528Bonalive Orthopedics granulesBonalive Biomaterials, Ltd.Jul 11, 2023SESE
K223915TactosetAnika Therapeutics, Inc.Mar 29, 2023SESE
K230054DSM Biomedical Calcium Phosphate CementDsm BiomedicalMar 21, 2023SESE
K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.Feb 3, 2023SESE
K220337GaiaBone Bioabsorbable Bone GraftCorliber (Shenzhen) Medical Device Co., Ltd.Feb 3, 2023SESE
K223563OsteoCNXConverg EngineeringJan 25, 2023SESE
K221726Uni-FuZe-C Bone StripZavation Medical Products, LLCJan 18, 2023SESE
K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.Dec 20, 2022SESE
K221644Synthetic Bone PuttyVentris MedicalSep 2, 2022SESE
K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc.Aug 23, 2022SESE
K221256Mg OSTEOINJECTBone Solutions, Inc.Jun 28, 2022SESE
K213959MagnetOs Flex MatrixKuros Biosciences B.VApr 14, 2022SESE
K212721Genex Bone Graft SubstituteBiocomposites, Ltd.Feb 4, 2022SESE
K212991OsteoreviveBone Solutions, Inc.Jan 21, 2022SESE
K213111MagnetOs granulesKuros Biosciences B.VJan 10, 2022SESE
K213342PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyincJan 5, 2022SESE
K212156ABCcolla Bone MatrixAcro Biomedical Co., Ltd.Oct 8, 2021SESE
K212135Dry DBM- A PuttySeaspine CorporationOct 4, 2021SESE
K212353DB-EZ Bone Void FillerDimensional Bioceramics, LLCSep 22, 2021SESE
K211201MagnetOs Easypack PuttyKuros Biosciences B.VSep 2, 2021SESE
K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.Aug 31, 2021SESE
K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.May 4, 2021SESE
K202639si-MochiBiostone, Ltd.Apr 21, 2021SESE
K210193DB-CompositeDimensional Bioceramics, LLCMar 15, 2021SESE
K201781Uni-FuZe-P Bone PuttyZavation Medical Products, LLCDec 28, 2020SESE
K200507PRO-DENSE LoVisc Bone Graft SubstituteWrightmedicaltechnologyincOct 21, 2020SESE
K201535Cerament Bone Void FillerBonesupport ABOct 16, 2020SESE
K200064OsteoFlo NanoPutty-Quadphasic Synthetic Bone GraftSurGenTec, LLCAug 14, 2020SESE
K191670CureOs TCPLinacol Muh Dan Kim Cev Tek Med Ith Ihr San VE TicAug 4, 2020SESE
K201464Altapore MISBaxter Healthcare CorporationJun 30, 2020SESE
K193513SIGNAFUSE Bioactive Bone GraftBioventusJun 18, 2020SESE
K193075Osteo3 ZP PuttySirakoss , Ltd.Jun 9, 2020SESE
K200290Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT)SeaSpine Orthopedics CorporationMay 11, 2020SESE
K200640ALTAPORE SHAPEBaxter Healthcare CorporationMay 8, 2020SESE
K200752DB-OrthopedicsDimensional Bioceramics, LLCApr 22, 2020SESE
K193487Agilon StripBiogennix, LLCMar 30, 2020SESE
K193168Agilon MoldableBiogennix, LLCFeb 13, 2020SESE
K190956SCS 17-01Anika Therapeutics, Inc.Jan 30, 2020SESE
K192363AltaporeBaxter Healthcare CorporationJan 9, 2020SESE
K193040Resorbable Mesh DeviceSeaSpine Orthopedics CorporationNov 30, 2019SESE
K191974NuVasive AttraX PuttyNu Vasive, IncorporatedNov 3, 2019SESE
K191513Altapore ShapeBaxter Healthcare CorporationOct 19, 2019SESE
K191074Sorrento Bone Graft SubstituteXenco Medical, LLCSep 27, 2019SESE
K190371Morpheus-CBiogennix, LLCAug 9, 2019SESE
K191274BonAlive GranulesBonalive Biomaterials, Ltd.Aug 7, 2019SESE
K191764Inion BioRestoreInion OYJul 31, 2019SESE
K190754Orthoss(R)Geistlich Pharma AGJun 23, 2019SESE
K190814AccuFill Bone Substitute MaterialZimmer Knee CreationsJun 10, 2019SESE
K190482IGNITE Bone Void FillerWrightmedicaltechnologyincMay 28, 2019SESE
K190110NanoBone SBX PUTTY, NanoBone QDArtoss GmbHApr 23, 2019SESE
K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.Mar 21, 2019SESE
K190283PROSTIM Injectable Inductive GraftWrightmedicaltechnologyincMar 14, 2019SESE
K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc.Dec 20, 2018SESE
K181958MagnetOs PuttyKuros Biosciences B.VDec 6, 2018SESE
K182823PRODENSE Bone Graft SubstituteWrightmedicaltechnologyincNov 2, 2018SESE
K180758Osteocera Resorbable Bone SubstituteWiltrom Corporation LimitedOct 24, 2018SESE
K181721Ceracell Ortho FoamCurasan AGSep 17, 2018SESE
K173933Sorrento Bioglass Bone Graft SubstituteXenco Medical, LLCSep 13, 2018SESE
K181255PRODENSE Bone Graft SubstituteWrightmedicaltechnologyincSep 12, 2018SESE
K173424BioSphere FlexSynergy BiomedicalSep 12, 2018SESE
K182107CarriGen PFEtex CorporationAug 31, 2018SESE
K181225ALTAPOREBaxter Healthcare CorporationAug 31, 2018SESE
K181306Actifuse FlowBaxter Healthcare CorporationAug 17, 2018SESE
K180853EP Granules™ BVFElute, Inc.Aug 6, 2018SESE
K181585JGH1 Core Deccompression Procedure KitAgNovos Healthcare USA, LLCJul 20, 2018SESE
K181342JGH1 Bone Graft SubstituteAgNovos Healthcare USA, LLCJul 19, 2018SESE
K173572DSM Biomedical Calcium Phosphate Cement with MicrospheresKensey Nash Corporation Dba Dsm BiomedicalMay 9, 2018SESE
K180121Rafugen DBMCellumed Co., Ltd.Apr 11, 2018SESE
K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.Apr 6, 2018SESE
K173525NovoGroOsteonovus, Inc.Apr 6, 2018SESE
K173362DSM Biomedical Calcium Phosphate CementKensey Nash Corporation Dba Dsm BiomedicalApr 3, 2018SESE
K171568SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse PuttyHans Biomed CorporationFeb 22, 2018SESE
K172237Bicera Resorbable Bone SubstituteWiltrom Corporation LimitedFeb 2, 2018SESE
K171629ABCcolla Bone GraftAcro Biomedical Co., Ltd.Feb 1, 2018SESE
K173301BioSphere MIS Putty (BioSphere MIS)Synergy Biomedical, LLCJan 19, 2018SESE
K170165Osteo-P Bone Graft SubstituteMolecular Matrix, Inc.Dec 29, 2017SESE
K173008SCS 17-01Anika Therapeutics, Inc.Dec 26, 2017SESE
K172573ReBOSSIS85Orthorebirth Co., Ltd.Dec 15, 2017SESE
K172497NuVasive AttraX ScaffoldNu Vasive, IncorporatedNov 24, 2017SESE
K172130Resorbable Mesh DeviceSeaSpine Orthopedics CorporationNov 16, 2017SESE
K170917Bi-Ostetic Bioactive Glass FoamBerkeley Advanced BiomaterialsOct 30, 2017SESE
K171161Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)Dimensional Bioceramics, LLCSep 25, 2017SESE
K171563MagnetOs PuttyKuros Biosciences B.VAug 24, 2017SESE
K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.Jun 30, 2017SESE
K170620ReBOSSIS85Orthorebirth Co., Ltd.Jun 23, 2017SESE
K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc.May 24, 2017SESE
K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.May 2, 2017SESE
K162087NovoGroOsteonovus, Inc.Apr 18, 2017SESE
K161859MagnetOsXpand Biotechnology BVFeb 24, 2017SESE
K1619960.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSEAmend Surgical, Inc.Feb 16, 2017SESE
K162860MCS Bone GraftBioventus, LLCFeb 13, 2017SESE
K163310NovaBone IRMNovabone Products, LLCJan 18, 2017SESE
K160566Cerasorb Ortho FoamCurasan AGDec 2, 2016SESE
K160446MCP Bone PuttyBiostructures, LLCNov 7, 2016SESE
K161351NanoBone SBX PuttyArtoss GmbHOct 26, 2016SESE
K161447HydroSet XTOrthovita, Inc.Oct 6, 2016SESE
K152077MaxiGenHans Biomed Corp.Apr 21, 2016SESE
K151271BellaFuseHans Biomed Corp.Mar 11, 2016SESE
K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.Feb 12, 2016SESE
K152589Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.Jan 12, 2016SESE
K151154FIBERGRAFT BG MorselsProsidyan, Inc.Nov 10, 2015SESE
K151584AttraX PuttyProgentix Orthobiology BVOct 8, 2015SESE
K150064Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)Orthogem, Ltd.Sep 4, 2015SESE
K152071NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)Novabone Products, LLCAug 26, 2015SESE
K143692GranOSTM - beta tricalcium phosphate synthetic bone granulesTcm Associates, Ltd.Aug 21, 2015SESE
K150621OsteoSelect PLUS Demineralized Bone Matrix PuttyBacterin International, Inc.Aug 18, 2015SESE
K151172MASTERGRAFT ContainMedtronic Sofamor Danek USA, Inc.Aug 14, 2015SESE
K141725BONGOLD BONE GRAFT MATERIALBeijing Allgens Medical Science & Technology Co, LJul 9, 2015SESE
K143533FIBERGRAFT BG PUTTY BONE GRAFT SUBSTITUTEProsidyan, Inc.Mar 25, 2015SESE
K141429SORRENTO BONE GRAFT SUBSTITUTEHaider Biologics, LLCFeb 23, 2015SESE
K132868CARRICELLEtex CorporationFeb 20, 2015SESE
K140913NUROS BONE GRAFT SUBSTITUTEOriental Resources Development LimitedFeb 17, 2015SESE
K141189NANOBONE / GRANULATEArtoss GmbHJan 30, 2015SESE
K141830STIMULAN KIT, STIMULAN RAPID CUREBiocomposites, Ltd.Jan 23, 2015SESE
K142104NANOFUSE DBMNanotherapeutics, Inc.Jan 21, 2015SESE
K142276MCS Bone GraftBiostructures, LLCJan 16, 2015SESE
K142828osteoSPAN MorpheusBiogennixJan 15, 2015SESE
K143549Vivorte TrabexusVivorte, Inc.Jan 14, 2015SESE
K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.Dec 18, 2014SESE
K141207NOVABONE BIOACTIVE STRIPNovabone Products, LLCOct 31, 2014SESE
K142090REBOSSISOrthorebirth Co., Ltd.Oct 29, 2014SESE
K141600NANOSS BIOACTIVE, NANOSS BIOACTIVE LOADED, AND NANOSS BIOACTIVE LOADED KITPioneer Surgical Technology, Inc. (Rti Surgical, IOct 17, 2014SESE
K141824MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIPMedtronic Sofamor Danek, Inc.Sep 5, 2014SESE
K133678CONFIRM BIOACTIVEGlobus Medical, Inc.Aug 26, 2014SESE
K140946NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITENovabone Products, LLCAug 22, 2014SESE
K141956FIBERGRAFT BG MORSELSProsidyan, Inc.Aug 13, 2014SESE
K141746AS20 COMPOSITE GRAFTWrightmedicaltechnologyincAug 4, 2014SESE
K132211SKAFFOLD NMX BONE VOID FILLERSkeletal Kinetics, LLCAug 4, 2014SESE
K141841INTEGRA MOZAIK OSTEOCONDUCTIVE SCAFFOLD - STRIPIntegra Lifescience CorportationAug 1, 2014SESE
K140844BIOSPHERE BIOACTIVE BONE GRAFT PUTTY, 2.5CC, 5CC, 10CCSynergy Biomedical, Inc.Jul 16, 2014SESE
K132470SOLUM IV BONE VOID FILLERSpinesmith Partners, LlpMay 21, 2014SESE
K132377OSTEOSPAN MORPHEUSBiogennix, LLCMay 20, 2014SESE
K140375MASTERGRAFT PUTTY, MASTERGRAFT STRIPMedtronic Sofamor Danek USA, Inc.Apr 18, 2014SESE
K130531ULTRAFUSEBaxter Healthcare CorpApr 8, 2014SESE
K132656PRODENSE BONE GRAFT SUBSTITUTEWrightmedicaltechnologyincMar 24, 2014SESE
K132805BG MORSELSProsidyan, Inc.Mar 14, 2014SESE
K132050NB3D BONE VOID FILLERPioneer Surgical Technology, Inc.Feb 7, 2014SESE
K132071BIOACTIVE BONE GRAFT PUTTYBiostructures, LLCJan 10, 2014SESE
K130977SIGNIFY BIOACTIVEGlobus Medical, Inc.Dec 24, 2013SESE
K131673MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFTMedtronic Sofamor Danek USA, Inc.Oct 3, 2013SESE
K130392KINEX BIOACTIVEGlobus Medical, Inc.Aug 15, 2013SESE
K131133VIVORTE BVF LITEVivorte, Inc.Aug 12, 2013SESE
K130953NEOTIS; NEOTIS 50Sbm Sciences For Bio MaterialsJul 15, 2013SESE

Top Applicants

Innolitics

Panel 1

/
Sort by
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from the tree

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...