Design and Development of Magnesium-Based Suture Anchor for Rotator Cuff Repair Using Finite Element Analysis and In Vitro Testing

A suture anchor is a medical device commonly used in rotator cuff repair surgery to attach tendons to the greater tuberosity of the humerus. Patient- and device-related factors, such as structural designs and poor bone density, can cause unsatisfactory clinical results. In this study, a new suture anchor design with four distinctive parameters was proposed, and the structural performance was optimized in a full factorial experimental design using finite element analysis. Two types of bone blocks—normal and osteoporotic bone—which received screw implants, were simulated to investigate the parametrical effects on various bone qualities. The prescribed motion at a constant removal velocity was used to evaluate the pullout strength. The von Mises criterion was employed in a force control simulation for topology optimization. Moreover, mechanical tests guided by ASTM-F543-17 were conducted for validation. This paper demonstrates the comprehensive process for developing a suture anchor with sufficient mechanical integrity for clinical use and clarifies the contributions of each distinctive design parameter in this application.