The metallic components of the device are manufactured from medical grade titanium alloy – Titanium 6Al-4V (ASTM F1472 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications) and commercially pure titanium (ASTM F1580 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coating of Surgical Implants).
Further information regarding ASTM Standards can be found online at: https://www.astm.org/industry/health-care-and-medical-devices-standards.html. These standards describe the constituent element and alloy composition allowed in the metal. These standards may be purchased online. Orthofix cannot provide copies of the standards since they are copyrighted material. The remaining components are derived from medical grade polymers. The core and sheath are made of polycarbonate urethane (PCU), and the fiber surrounding the core is made of ultra-high molecular weight polyethylene (UHMWPE). These polymer materials are proprietary to third-party suppliers, and are not subject to a material composition standard (such as an ASTM standard).
Return to Frequently Asked Questions about the M6-C artificial disc here.