510(k) Report

Devices descending from K922489

132 later devices reach Medpor Surg Implant Material:Prefor Cran/Fac Impla through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160988Biopor, AOC Porous Polyethylene, CereporCeremed, Inc.20160—
+1K140437SU-Por Surgical ImplantPoriferous, LLC20142—
+1K123908Omnipore Surgical Implants and AccessoriesMatrix Surgical USA201353
+1K091120Medpor Contain ImplantPorex Surgical, Inc.20101—
+1K083621Medpor Customized Surgical ImplantPorex Surgical, Inc.200929—
+1K043133Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant…Ceremed, Inc.200543—
+1K022665Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including…Hohenstein Enterprises, Inc.200246—
+1K970400Bone Source HydroxyapatiteOrthofix, Inc.199750—
+1K960656Gore Burr Hole CoverW. L. Gore & Associates, Inc.19960—
+2K211514Longeviti PorousFit implantLongeviti Neuro Solutions, LLC20210—
+2K183472DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR ConditionalSynthes (USA) Products, LLC20190—
+2K171037PoreStar Patient Specific ImplantAnatomics Pty, Ltd.20171—
+2K152463SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantPoriferous, LLC20160—
+2K132920Spirox Inex DeviceSpirox, Inc.20144—
+2K133046Omnipore Customized Surgical ImplantsMatrix Surgical Holdings, LLC/Matrix Surgical USA201401
+2K121315Stryker CMF Medpor Customized ImplantHowmedica Osteonics Corp.20125—
+2K111065Stryker (R) Patient Specific Polymer ImplantHowmedica Osteonics Corp. Dba Stryker Orthopeadics201120—
+2K102184Medpor Contain Can ImplantPorex Surgical, Inc.20110—
+2K080507Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical ImplantCeremed, Inc.20089—
+2K071937Bonalive Granules and Bonalive PlatesVivoxid, Ltd.20070—
+2K062280Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and ActipasteCeremed, Inc.200638—
+2K021440Bonesource HacStryker Instruments200243—
+2K991398Bonesource Hydroxyapatite Cement (Hac) Expanded KitStryker Leibinger199945—
+2K973789Norian Cranial Repair System (CRS)Bone Cement- 5CC Kit, Norian Cranial Repair System…Norian Corp.199849—
+3K223167Spirair Nasal Septal StrapSpirair, Inc.20233—
+3K200532StarPoreAnatomics Pty, Ltd.20200—
+3K143661DirectInjectStryker201501
+3K143173Stryker CMF MEDPOR Customized ImplantStryker20154—
+3K121153Peek Customized Craial Implant KitStryker201213—
+3K111323Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsSynthes, Inc.20112—
+3K111538Skaffold CisSkeletal Kinetics, LLC201118—
+3K102018Norian Reinforced, Norian Reinforced Fast Set PuttySynthes USA Products, LLC20100—
+3K081531Aoc Soluble Implant MaterialCeremed, Inc.20085—
+3K070093Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc.200729—
+3K060445Norian CRS Bone CementSynthes (Usa)200601
+3K032366Bonesource Hac Fast Setting CementStryker Instruments200341—
+3K031435Bonesource BVFHowmedica Osteonics20030—
+3K011736DRG QuickmixDoctor'S Research Group, Inc.20020—
+3K983104Norian Periodontal/Dental Cement (PDC)Norian Corp.19992—
+4K233569SeptAlignSpirair, Inc.20242—
+4K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)Kelyniam Global, Inc.20194—
+4K153248PEEK Customized Cranial ImplantStryker20162—
+4K153508Stryker CMF MEDPOR Customized ImplantStryker20162—
+4K152076PEEK Customized Cranial Implant, PEEK Customized Cranial Implant PriorityStryker20150—
+4K142348OsteoSeal Bone HemostatHemostasis, LLC20150—
+4K141502HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201413—
+4K133809Osteofab Patient Specific Facial DeviceOxford Performance Materials20141—
+4K132519Stryker Customized Mandible Recon Plate KitStryker20133—
+4K123243Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyOrthocon, Inc.201316—
+4K120220Adaptain Soluble Implant MaterialCeremed, Inc.20122—
+4K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal20111—
+4K103047Ceretene Soluble Implant MaterialCeremed, Inc.20110—
+4K082491Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene &…Ceremed, Inc.200828—
+4K082245Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LVCeremed, Inc.20080—
+4K043334Bone Source Hac Rapid Setting CementStryker Instruments200536—
+4K042072Callos CMF Bone Void FillerSkeletal Kinetics, LLC2004310
+5K261058CraniUS PlateCraniUS, LLC20261—
+5K251790SeptAlignSpirair, Inc.20261—
+5K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.20250—
+5K242050Montage Settable Bone PuttyOrthocon, Inc.20241—
+5K231834VSP PEEK Cranial Implant3D Systems, Inc.20240—
+5K213260CMFlexTMDimension Inx Corp.20220—
+5K220315MONTAGE-XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20221—
+5K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc.20212—
+5K193136Stryker Customized Mandible Recon Plate KitStryker20201—
+5K191916Stryker CMF MEDPOR Priority Customized Implant KitStryker Leibinger GmbH & Co KG20191—
+5K190229Stryker PEEK Customized Cranial Implant KitStryker20191—
+5K190696Stryker Surgeon iD Mandible Recon PlateStryker20190—
+5K153317HEMASORBPLUS Resorbable Hemostatic Bone PuttyOrthocon, Inc.20160—
+5K161052OsteoFab Patient Specific Facial DeviceOxford Performance Materials, Inc.20160—
+5K153095ROP Resorbable Hemostasis MaterialResorbable Orthopedic Products, LLC20160—
+5K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.201512—
+5K143069HEMASORBPLUS press Resorable Hemostatic Bone PuttyOrthocon, Inc.20140—
+5K122561Adaptain Fastwrap, Envelock, GraftainCeremed, Inc.20121—
+5K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation20115Class I
+5K103822Synthes Hemostatic Bone Putty (HBP)Synthes USA Products, LLC20110Class I
+5K091636Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc.200920—
+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
+6K262874CraniUS PlateCraniUS, LLC20260—
+6K262769Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)Orthocon, Inc.20260—
+6K260620SeptAlign (SPLN001)Spirair, Inc.20260—
+6K261439Permatage Flowable, Settable Hemostatic Bone PasteOrthocon, Inc.20260—
+6K254233MEDPOR Customized Implant KitStryker Leibinger GmbH & Co KG20260—
+6K243506Montage-XT Settable Bone PuttyOrthocon, Inc.20240—
+6K241027Permatage Settable Bone PuttyOrthocon, Inc.20242—
+6K232771Montage Flowable Settable, Resorbable Bone PasteOrthocon, Inc.20240—
+6K231475MONTAGE-QS Settable, Resorbable Bone PuttyOrthocon, Inc.20230—
+6K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc.20233—
+6K221933MONTAGE Settable, Resorbable Bone PuttyOrthocon, Inc.20231—
+6K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)20220—
+6K203055Stryker PEEK Customized Cranial Implant KitStryker20210—
+6K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc.20193—
+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