Why Genesis PEEK
Genesis PEEK® is Genesis Medical Plastics’ brand for its long-term implantable PEEK resin, stock shapes and film products. They meet the requirements of ASTM F2026 Standard Specification for PEEK Polymers for Surgical Implant Applications and ISO 10993 Standard for biological evaluation of implantable medical devices exposed to bodily tissue and fluids long-term, or 30 days or more.
How is Genesis PEEK Different from Medical Grade PEEK?
Genesis PEEK semi-finished shapes and film comply with the most current version of ASTM F2026 Standard Specification. Compliance is essential for implantable medical devices that are in contact with bodily tissue and fluids for prolonged periods beyond 30 days. The comprehensive ASTM F2026 standard includes a for meeting ISO 10993.
Implantable shapes and film products offered by Genesis are extruded from PEEK resin that also meets or exceeds requirements of the latest version of ASTM F2026. The PEEK resin is produced in a cGMP clean room setting and in accordance with ISO 10993.
In contrast, medical grade semi-finished PEEK shapes are extruded from resin that satisfies ISO 10993 for devices exposed to bodily tissue and fluids for short periods, or up to 24 hours.
Are Implantable Genesis PEEK Properties Different from Medical Grade PEEK?
Both versions of the resin and Genesis’ semi-finished shapes made from them have the physical properties and resistance to chemicals and sterilization inherent in the basic PEEK polymer.