510(k) Report

Devices descending from K873689

92 later devices reach Cranioplastic, Acrylic Cranioplasty Material through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072601Osteosymbionics Patient Specific Cranial ImplantOsteosymbionics, LLC200720—
+1K071791Modification to Cranioplastic, Model 43-1280Codman & Shurtleff, Inc.20070—
+1K043406Vertebroplastic Radiopaque Bone CementDepuy Spine, Inc.20053—
+1K042414Visioplast Acrylic ResinTecres20041—
+1K040152Bone Cement for CranioplastyCardinalhealth20041—
+1K023575Concert CranioplastImmedica, Inc.20030—
+1K994022Parallax CraniosetParallax Medical, Inc.20000—
+1K991893Parallax Tracer Radiopaque ParticlesParallax Medical, Inc.19992—
+1K964537Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc.199750—
+1K953339Bonesource Hydroxyapatite Cement (Hac)Osteogenics, Inc.199655—
+2K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC20184—
+2K133082Osteosymbionics Patient-Specific Cranial PlateOsteosymbionics, LLC20145—
+2K121818Osteofab Patient Specific Cranial DeviceOxford Performance Materials20131—
+2K121102Osteosymbionics Peek Cranial ImplantOsteosymbionics, LLC20122—
+2K110684Medcad Accushape (TM) Peek Patient Specific Cranial / Craniofacial ImplantVanduzen Dba Medcad201111—
+2K103582Kelyniam Custom Skull Implant (Csi)Kelyniam Global, Inc.201184
+2K091382Kryptonite Bone CementDoctors Research Group, Inc.200901
+2K071927Modification to Vertebroplastic Radiopaque Bone CementDepuy Spine, A Johnson & Johnson Company20072—
+2K063438VspspnTecres S.P.A.20070—
+2K023445Tracers Bone Cement OpacifierParallax Medical, Inc.20031—
+2K021440Bonesource HacStryker Instruments200243—
+2K991398Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger199945—
+2K983009BSM- Bone Substitute MaterialEtex Corp.19984—
+2K973789Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System…Norian Corp.199849—
+3K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+3K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantMedcad20222—
+3K201831CONFIDENCE Spinal Cement SystemDepuy Spine, Inc.20200—
+3K191210Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC20203—
+3K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+3K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc.20180—
+3K143661DirectInjectStryker201501
+3K121755Custom Craniofacial Implant (Cci)Kelyniam Global, Inc.20125—
+3K112907Confidence High Viscosity Spinal Cement, 16G / 20GMedos International SARL20110—
+3K102018Norian Reinforced, Norian Reinforced Fast Set PuttySynthes USA Products, LLC20100—
+3K091729Alpha-BSM, Beta-BSM, Gamma-BSM, EquivaboneEtex Corp.20092—
+3K060445Norian CRS Bone CementSynthes (Usa)200601
+3K033230Tracers TA Bone Cement Opacifier, Model TCR-TAParallax Medical, Inc.20030—
+3K032366Bonesource Hac Fast Setting CementStryker Instruments200341—
+3K032307Cap Bone Substitute MaterialEtex Corp.20033—
+3K031435Bonesource BVFHowmedica Osteonics20030—
+3K011736DRG QuickmixDoctor'S Research Group, Inc.20020—
+3K983104Norian Periodontal/Dental Cement (PDC)Norian Corp.19992—
+4K261058CraniUS PlateCraniUS, LLC20261—
+4K252251Easymade-TICG Bio Co., Ltd.20260—
+4K243715Synthes Patient Specific ImplantsSynthes GmbH20250—
+4K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+4K203349Longeviti ClearFit Cranial ImplantLongeviti Neuro Solutions, LLC20202—
+4K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+4K100883CarrigenEtex Corp.20100—
+4K102812Gamma-BSM; Beta-BSM; EquivaboneEtex Corporation20100—
+4K043334Bone Source Hac Rapid Setting CementStryker Instruments200536—
+4K042072Callos CMF Bone Void FillerSkeletal Kinetics, LLC2004310
+5K262874CraniUS PlateCraniUS, LLC20260—
+5K231920Longeviti ClearFit OTS Cranial ImplantLongeviti Neuro Solutions, LLC20231—
+5K213260CMFlexTMDimension Inx Corp.20220—
+5K070012PolyboneKyung Won Medical Co., Ltd.20070—
+5K060763Stryker Injectable CementStryker200681
+5K060750Stryker Injectable CementStryker Cmf20060—
+5K060061Stryker Injectable CementStryker Corp.200630—
+5K051603Stryker Injectable CementStryker Leibinger Micro Implants20053—
+5K051784Osteovation CMF Bone Void FillerSkeletal Kinetics, LLC2005213
+6K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…Longeviti Neuro Solutions20260—
+6K241027Permatage Settable Bone PuttyOrthocon, Inc.20242—
+6K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.20240—
+6K231475MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+6K221933MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20231—
+6K173572DSM Biomedical Calcium Phosphate Cement with MicrospheresKensey Nash Corporation Dba Dsm Biomedical20180—
+6K173362DSM Biomedical Calcium Phosphate CementKensey Nash Corporation Dba Dsm Biomedical20183—
+6K162864OsteoVation ImpactSkeletal Kinetics, LLC201717
+6K161447HydroSet XTOrthovita, Inc.2016102
+6K140309CranioplugOssdsign AB20142—
+6K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc.20092—
+6K071876Cross.BoneTriMed, Inc.20070—
+7K261265Permatage XT Settable Bone PuttyOrthocon, Inc.20260—
+7K253732Permatage Flowable, Settable Bone PasteOrthocon, Inc.20260—
+7K253854MONTAGE XT Cranial CementOrthocon, Inc.20260—
+7K231903Montage-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+7K230054DSM Biomedical Calcium Phosphate CementDsm Biomedical20230—
+7K222063MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20233—
+7K212991OsteoreviveBone Solutions, Inc.20221—
+7K182742DB-CMFDimensional Bioceramics, LLC20190—
+7K181539OSSDSIGN CranioplugOssdsign AB20181—
+7K173008SCS 17-01Anika Therapeutics, Inc.20174—
+8K253447Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)Orthocon, Inc.20260—
+8K233566Montage-XT Settable, Resorbable Bone PuttyOrthocon, Inc.20241—
+8K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+8K223915TactosetAnika Therapeutics, Inc.20231—
+8K221256Mg OSTEOINJECTBone Solutions, Inc.20220—
+8K212083Tactoset Injectable Bone SubstituteAnika Therapeutics, Inc.20212—
+8K190956SCS 17-01Anika Therapeutics, Inc.20203—
+9K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+9K231968Tactoset® Injectable Bone SubstituteAnika Therapeutics, Inc.20230—