Fatigue Testing the Tibial Tray Component

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Fatigue Testing the Tibial Tray Component

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.