Solvay Specialty Polymers’ Zeniva ® polyetheretherketone (PEEK), one of four products comprising its family of Solviva® Biomaterials offered for use in implantable devices, successfully passed biocompatibility testing at the China Food and Drug Administration’s Tianjin Medical Device Quality Supervision and Inspection Center.
Zeniva PEEK boasts a modulus very close to that of cortical bone, plus excellent fatigue resistance and toughness. It is offered for use in implantable medical devices for spine and orthopaedic applications. Zeniva PEEK may offer advantages over metals, such as reduction of stress shielding, no heavy metal allergy or ion erosion and radiolucent properties that allow x-ray and CT scanning procedures without interference.
Solviva Biomaterials can be sterilized using all conventional methods including gamma radiation, ethylene oxide, and steam. These sterilizable products are available in grades for injection molding or extrusion, as well as stock shapes for machined components.
Source: Solvay Specialty Polymers
In August 2015, Solvay launched an expansion at its Augusta manufacturing facility to install the first world-scale PEEK resin production unit in the U.S., supporting demand for KetaSpire® and AvaSpire® ultra-polymers used in medical devices and other applications. Completion is expected in mid-2016.
For those interested in device approval in China, the EMERGO Group’s Evangeline Loh, Ph.D., RAC (US & EU), Vice President of Global Regulatory Affairs, will share regulatory and registration requirements and strategies for approval in Asia Pacific markets at OMTEC 2016. Her session is titled Strategies for Device Approval in China, India, South Korea and Austrlia. Click here for more information.