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
- ISO 14879 Fatigue of Knee-Joint Prostheses -- Endurance Properties of Knee Tibial Trays Test Machines
- ISO 15108 Bending Shear of Adhesives Test Equipment
- ASTM F1800 Fatigue Knee Joint Replacement Test Equipment
Recommended Test Machine
Static and fatigue forces up to 50 kN (11,250 lbf)
Frequency ratings up to 75 Hz
Oil-free, all electric actuator for clean test conditions
Lower purchase, operating, and maintenance costs than hydraulic equivalents