Solvay Speciality Polymers Zeniva polyetheretherketone (PEEK) has passed Chinese biocompatibility testing for implantable devices
Solvay’s Zeniva PEEK is one of the four products comprising its family of Solviva Biomaterials offered for use in implantable devices and passed the biocompatibility testing at the China Food and Drug Administration’s (FDA) Tianjin Medical Device Quality Supervision and Inspection Center.
Kendra Shoulders, director of global regulatory affairs for healthcare, Solvay, said: “Obtaining this important biocompatibility testing report facilitates the strategic implementation and launching of Solviva Biomaterials in the China market place.
“This essential recognition will help local medical OEMs to gain regulatory approval from the China Food and Drug Administration for their implantable devices.”
The test took over a year to complete and during this process, properties of Zeniva PEEK such as sensitisation, intracutaneous toxicity, acute systemic toxicity, sub-chronic toxicity, genotoxicity and bone implant compatibility tests were examined to ensure biological safety in the human body, according to Solvay.
Luke Du, managing director Asia, and executive vice president Solvay, said: “Obtaining this local and important biocompatibility testing report for Zeniva PEEK signals our further commitment to both national and multi-national medical OEMs.”
Zeniva PEEK is offered for use in implantable medical devices for spine, orthopedics, cardiovascular and dental applications.
Solvay’s family of Solviva Biomaterials has been commercially available in China since 2013.
Solviva Biomaterials can be sterilised using all conventional methods including gamma radiation, ethylene oxide and steam. These sterilisable products are available in grades for injection molding or extrusion, as well as stock shapes for machined components, according to Solvay.
The entire range of thermoplastic Solviva Biomaterials is manufactured in an ISO 13485 registered facility and under the relevant aspects of current Good Manufacturing Practices.
Solvay’s biomaterial manufacturing processes are carefully validated, and enhanced controls provide product traceability. In addition, all materials are tested in an ISO 17025 accredited lab.