Bone Plates Runout Prediction Through Tensile Strength and Geometric Properties for Regulatory Mechanical Testing.

Mechanical tests on bone plates are mandatory for regulatory purposes and, typically, the ASTM F382 standard is used, which involves a four-point bending test setup to evaluate the cyclic bending fatigue performance of the bone plate. These test campaigns require a considerable financial outlay and long execution times; therefore, an accurate prediction of experimental outcomes can reduce test runtime with beneficial cost cuts for manufacturers. Hence, an analytical framework is here proposed for the direct estimation of the maximum bending moment of a bone plate under fatigue loading, to guide the identification of the runout load for regulatory testing. Eleven bone plates awaiting certification were subjected to a comprehensive testing campaign following ASTM F382 protocols to evaluate their static and fatigue bending properties. An analytical prediction of the maximum bending moment was subsequently implemented based on ultimate strength and plate geometry. The experimental loads obtained from fatigue testing were then used to verify the prediction accuracy of the analytical approach. Results showed promising predictive ability, with R coefficients above 0.95 in the runout condition, with potential impact in reducing the experimental tests needed for the CE marking of bone plates.