510(k) Report

Devices descending from K013072

137 later devices reach Chronos Tricalcium Prosphate (Chronos TCP) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142463Bio2 CLM BG Bioactive ScaffoldBio2 Technologies, Inc.20141—
+1K071046Synthes Chronos CompositeSynthes (Usa)20079—
+1K061499OsferionOlympus America, Inc.200773—
+1K051775Osteomimetic Synthetic Bone MatrixBiomimetic Pharmaceuticals, Inc.20050—
+1K032409Vitoss Scaffold Synthetic Cancellous Bone Void FillerOrthovita, Inc.200355—
+1K030178Calcigen Psi Bone Graft SubstituteBiomet, Inc.20033—
+2K253524Adaptos®Fuse Bone GraftBiomendex OY20260—
+2K191974NuVasive AttraX PuttyNu Vasive, Incorporated201971—
+2K171563MagnetOs PuttyKuros Biosciences B.V20174—
+2K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+2K143692GranOSTM - beta tricalcium phosphate synthetic bone granulesTcm Associates, Ltd.20150—
+2K123633TRS Cranial Bone Void Filler (TRS C-BVF)Tissue Regeneration Systems, Inc.20130—
+2K111944NB3D Bone Void FillerPioneer Surgical Technology, Inc.20111—
+2K083033Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive…Orthovita, Inc.200847—
+2K080065OsferionOlympus Terumo Biomaterials Corporation20080—
+2K062691ComporusTakiron Co., Ltd.20080—
+2K063157Merries K-Phate Bone Graft SubstituteMerries International, Inc.20080—
+2K062200Collagen Matrix Anorganic Bone Mineral Bone Graft MaterialsCollagen Matrix, Inc.20070—
+2K061311Allogran-RBiocomposites, Ltd.20060—
+2K050490Osmosys Calcium Phosphate Ceramic Bone FillerMedicrea20050—
+2K041616Bgran Synthetic Osteoconductive ScaffoidOrthos (Uk) Limited20042—
+2K032286Calcigen Psi Bone Graft SubstituteBiomet Orthopedics, Inc.20031—
+3K240450Citrepore™Acuitive Technologies, Inc.20240—
+3K242280Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive…Stryker Spine20241—
+3K230736MagnetOs PuttyKuros Biosciences B.V20234—
+3K213111MagnetOs granulesKuros Biosciences B.V20227—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K211201MagnetOs Easypack PuttyKuros Biosciences B.V20213—
+3K203218CaP Spheres Pellet PackZimmer Biomet Spine, Inc.20210—
+3K182074Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20193—
+3K141207Novabone Bioactive StripNovabone Products, LLC20140—
+3K132050NB3D Bone Void FillerPioneer Surgical Technology, Inc.201401
+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—
+3K063346Pro Osteon 500REbi, L.P.20070—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K261008Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…Stryker Spine20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+4K250521NanoBone® SBX Putty ; NanoBone® QDBiocomposites, Ltd.20250—
+4K250556Porous Biologic ScaffoldVentris Medical20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc.20250—
+4K241167BioSphere Putty; BioSphere MIS PuttySynergy Biomedical20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K242299NovaBone Putty - Synthetic Bioactive Bone GraftNovabone Products, LLC20241—
+4K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation202402
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K240442MagnetOs PuttyKuros Biosciences B.V20243—
+4K240507NuVasive AttraX ScaffoldNuvasive, Inc.20240—
+4K240458Synthetic Bone PuttyVentris Medical20242—
+4K240459Cerament Bone Void FillerBonesupport AB20240—
+4K232347MagnetOs GranulesKuros Biosciences B.V20242—
+4K233607MagnetOs Easypack PuttyKuros Biosciences B.V20232—
+4K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC20232—
+4K233245MagnetOs Flex MatrixKuros Biosciences B.V20230—
+4K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20231—
+4K232315Catalyst Bone Void FillerOssdsign AB20237—
+4K231942Mineral Collagen Composite Bioactive Extra MoldableCollagen Matrix, Inc.20231—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K223915TactosetAnika Therapeutics, Inc.20231—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K213260CMFlexTMDimension Inx Corp.20220—
+4K221735Mineral Collagen Composite Bioactive MoldableCollagen Matrix, Inc.20222—
+4K222276CONDUIT Cages; FIBERGRAFT BG PuttyDepuy Spine202229—
+4K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody SystemNu Vasive, Incorporated20222—
+4K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc.20171—
+4K163621Vitoss Bioactive (BA) InjectableOrthovita, Inc.20172—
+4K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.20162—
+4K133678Confirm BioactiveGlobus Medical, Inc.20140—
+4K130703Vivorte BVFVivorte, Inc.201311
+4K130392Kinex BioactiveGlobus Medical, Inc.20138—
+4K113049Socket GraftSteiner Laboratories20120—
+4K101557Gamma-BSM, Beta-BSM, Equivabone, CarigenEtex Corp.201010—
+4K093447CarrigenEtex Corp.201021—
+5K262230Mg OSTEOREVIVE™;Mg OSTEOCRETE™Bone Solutions, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc.20250—
+5K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft…Prosidyan, Inc.20250—
+5K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+5K243474MagnetOs MISKuros Biosciences B.V20250—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K242797OsteoFlo HydroFiberSurGenTec, LLC20241—
+5K243609EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )Etex Corporation20240—