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Background: Orthodontic mini-implant failure is a debatable subject in clinical practice. However, the most important parameter to evaluate the success rate of mini-implant is the primary stability, which is mainly influenced by cortical bone thickness (CBT) and insertion angle. Materials and methods: Three-dimensional finite element models of the maxilla were created and a custom-made, self-drilling, tapered mini-implant was designed. For the pull-out test, 12 simulations were performed, sequentially increasing the thickness of the cortical bone (1, 1.5 and 2 mm) and the insertion angle (30&deg, 60&deg, 90&deg, 120&deg, ). For the force analysis, 24 simulations were performed using an experimental orthodontic traction force of 2 N both in the horizontal and vertical axis. Results: Insertion angle and CBT have significant impact on force reaction values (p &lt, 0.05). Cortical bone stress had the lowest value when the mini-implant had a 30&deg, insertion angle and the highest value when the implant had a 120&deg, insertion angle, while the CBT was 1 mm. Cortical bone stress had the lowest value with an insertion angle of 90&deg, and the highest value when the implant was inserted at an angle of 30&deg, while the CBT was 2 mm independent of the force direction. Regarding the biosafety profile of the mini-implant alloy, the present results reveal that the custom-made mini-implant presents good biocompatibility. Conclusions: When the CBT is reduced, we recommend inclined insertion while, when the CBT is appropriate, perpendicular insertion is advised.