A Polyaryletherketone Biomaterial for use in Medical Implant Applications

A polyaryletherketone biomaterial launched by Victrex® in 1998 and marketed as PEEK-OPTIMATM, is suitable for medical implant use, enabling device manufacturers to make high performance implants with tailored properties that are compatible with modern medical imaging techniques. This family of products, manufactured under conditions of ‘no change’ has been achieved using enhanced manufacturing procedures, backed-up with extra physical, chemical or mechanical testing at key stages of manufacture. Independent test laboratories have undertaken biocompatibility testing to the relevant parts of ISO 10993 and to USP plastics class VI with excellent results. DMF and MAF files containing the results of these tests have been lodged with the FDA. This paper describes aspects of PEEKOPTIMATM manufacture, testing and application.