Computer modeling and simulation (CM&S) technology is widely used in the medical device industry due to its advantages such as reducing testing time and costs. However, the developer’s parameter settings during the modeling and simulation process can have a significant impact on the results. This study developed a test model for the rotational shear strength of dental implants and the constraint force of total knee replacements based on CM&S technology and proposes ideal parameters to ensure reliability. For dental implants, the load area and sliding contact conditions were considered, and for total knee replacements, the friction coefficient, medial–lateral displacement, valgus–varus rotation, and elastic modulus were considered. By comparing the simulation results and mechanical tests, boundary conditions with an error rate of less than 1.5% were selected. When a jig (gripper and collector) was applied with the same boundary conditions, an error rate of 48~22% occurred; otherwise, it was confirmed that the error rate was within 10~0.2%. The FE model was verified with an error of 2.49 to 3% compared to the mechanical test. The friction coefficient variable had the greatest influence on the results, accounting for 10 to 13%, and it was confirmed that valgus–varus rotation had a greater influence on the results than medial–lateral displacement. Relatively, the elastic modulus of the insert had the least effect on the results. These research results are expected to make CM&S techniques useful as a medical device digital development tool (M3DT) in the development of total knee replacements and dental implants.
Background: Multilevel posterior spinal fusion to T10 often encounters complications such as screw loosening and proximal junctional kyphosis. Cement augmentation or prophylactic vertebroplasty is used to prevent these, but their biomechanical effects remain unclear. Methods: A validated finite element model (T8–pelvis) from CT data of a 57-year-old male was tested in five configurations: fusion only, fusion with cement augmentation at T10, T10–T11, T10–T11 plus T9 vertebroplasty, and T10–T11 plus T8–T9 vertebroplasty. Range of motion (ROM), intradiscal pressure (IDP), posterior ligament/facet stress, and cement–bone interface stresses were analyzed under a 400 N follower load and 10 N·m moments. Results: Cement augmentation at the upper instrumented vertebra produced <5% changes in ROM, IDP, and posterior ligament/facet stresses compared with fusion only, indicating preserved stability. Prophylactic vertebroplasty redistributed stress proximally, with elevated cement–bone interface stresses localized at T9 when vertebroplasty was performed at a single adjacent level (T9) and distributed to both T8 and T9 when performed at two adjacent levels (T8–9)—with T9 stressed mainly during lateral bending and extension, and T8 during flexion and lateral bending. Conclusion: Cement augmentation alone did not compromise adjacent-level biomechanics, but prophylactic vertebroplasty created abnormal stress concentrations at adjacent interfaces, potentially increasing fracture risk. These findings highlight the need for careful patient selection and further studies in osteoporotic populations.