Cypress, TX, June 20, 2023 — Genesis Medical Plastics now offers its own brand of PEEK film and thin sheet for fabricating intricate components for implantable medical devices. The company’s production technology yields quantities to support projects from testing through full production.
Genesis PEEK film and thin sheet and the PEEK resin from which they are made comply with ASTM F2026-17, essential for use in implantable devices. Genesis is also ISO 13485:2016 certified and FDA registered as a device manufacturing facility.
While implantable PEEK is widely used in medical devices, the vast majority of implant applications are made by machining extruded rod and plate or by injection molding. To fill the need for implantable PEEK film and thin sheet for device components, Genesis focused on engineering its own calendering technology. Its capabilities now provide efficient sizes of film for laser-cutting or stamping the small internal parts associated with defibrillators, pacemakers and other bioelectronic devices.
According to Stephen Kramer, Genesis General Manager, “The decision to introduce Genesis PEEK film was driven by device manufacturers seeking a well-qualified commercial source. Customers also needed small size formats, rather than large rolls common in film production. This led us to develop technology to calender yield-efficient sizes for precision parts in quantities suited to customers’ requirements.
Genesis film and sheet production width is 100mm (4 inches). Standard thicknesses range from 0.254 mm (0.010-inch) to 1.106 mm (0.040-inch). Custom slit widths and made-to-order sizes are also available.
In addition to offering its new Genesis PEEK products, the company custom-produces film and thin sheet for device manufacturers who prefer to supply their own implantable PEEK from Invibio, Evonik, and from Solvay under their Zeniva brand.
About Genesis Medical Plastics
Genesis Medical Plastics based in Cypress, Texas is an ISO 13485:2016 certified company and an FDA Class II registered medical device manufacturer. It recently added calendering implantable PEEK film and thin sheet to its capabilities for converting customers’ medical polymers into custom configurations. Processes include extrusion of machinable rod and plate in a range of sizes, injection molding precision components, and CNC machining from prototypes to production quantities. Its production team has over two decades of processing experience in medical grade plastics from polypropylene through PEEK. Visit www.genesismedicalplastics.com for more information.