Orthotek Laboratory

ASTM International Journal Publishes Orthotek Laboratory's Research on Bone Screw Testing

Orthotek Lab November 3, 2025, 20:00, Shanghai

Recently, our research findings on the bone screw testing method were recognized by the ASTM standards organization and formally published in the ASTM journal "Journal of Testing and Evaluation".

ASTM F543, recognized globally as the "gold standard" for evaluating the performance of bone screws, profoundly influences both domestic and international industry regulations and serves as a critical reference for the formulation of China's YY/T standards. However, as screw types continue to evolve and application scenarios expand, whether the original standard still possesses sufficient applicability has become a significant challenge facing the industry. Orthotek Laboratory has taken on this challenge with robust data and rigorous methodologies.

The study encompassed 24 categories of bone screws, with samples covering a wide range of sizes and types, ensuring strong representativeness and persuasiveness. The experiments employed Orthotek's independently developed BST200 Screw Torsion Testing System to conduct multiple tests, including torsional failure, insertion/removal torque, and self-tapping performance, providing a solid data foundation for the research. While strictly adhering to the ASTM F543 standard, we did not limit ourselves to conventional insertion/removal torque measurements. Instead, we further introduced multi-dimensional metrics such as insertion rate, insertion rate without pre-drilling, and insertion efficiency curves, enabling a systematic assessment and scientific interpretation of screw insertion performance.

The research findings reveal room for optimization in the practical application of the ASTM F543 standard: 12% of the screws experienced insertion failure, and among the successful insertions, a significant 83% required pre-drilling to achieve rated feed efficiency. The axial force of 11.5N specified in the standard proved insufficient for some screws. We recommend a more scientific, dynamic setting that incorporates the screw's self-tapping force. Furthermore, Orthotek innovatively proposes a theory where the self-tapping force, calculated based on multiple physical parameters of the screw, serves as a reference for the insertion load. This offers a more flexible and precise alternative for setting the axial force.