Fatigue Test of Tibial Tray

For a total knee prosthesis, FDA recommends you provide a report of fatigue testing of the porous-coated metal tibial tray according to ASTM F1800. FDA recommends testing five samples at various loads to develop an applied force/number of cycles (AF/N) curve with at least one sample surviving 10 million cycles. For a unicompartmental knee prosthesis, no standardized test method currently exists for fatigue testing of the tibial baseplate component. FDA recommends that you provide adequate information (e.g., engineering analysis, comparison of materials/geometry to predicate devices, mechanical testing) to demonstrate that the new device is capable of withstanding the expected physiological loads to which it will be subjected.

Applicable Testing Standards

Recommended Test Machine