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AFO (Ankle-Foot Orthosis), which covers the ankle and foot, protects and supports the ankle joint as well as the structures around it. It contributes to the maintenance of the correct gait cycle. Owing to orthoses, the functional capacity of the body part is significantly improved, and so is the quality of life for the user. Personalized orthoses, which are adapted to the anatomy of the user, are more and more often produced by the additive methods. The use of 3D printing for the manufacturing medical devices is becoming increasingly common due to the low cost of the whole process, short production time and the possibility of the product personalization. One of the stages in manufacturing AFOs with the additive method is to create a three-dimensional model of the orthosis in CAD software. Finite element analysis was performed to assess the mechanical properties of the orthosis. The influence of geometry and the materials used were investigated with FEM analysis software. As a result of structural analysis during the design stage, the assessment of the medical device in terms of its durability and mechanical resistance without putting the user at risk is possible. On the basis of the obtained results, the structure strength was compared.