For total knee prostheses, the FDA recommends a reference to the ASTM F1800 porous coated metal neck fatigue test. The FDA recommends testing five samples under different loads to develop a force/quantity (AF/N) cycle curve containing at least one sample of 10 million cycles.
For total knee prostheses, the FDA recommends a reference to the ASTM F1800 porous coated metal neck fatigue test.
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