Additively manufactured custom load-bearing implantable devices: Grounds for caution

Background Additive manufacturing technologies are being enthusiastically adopted by the orthopaedic community since they are providing new perspectives and new possibilities. First applications were finalised for educational purposes, pre-operative planning, and design of surgical guides; recent applications also encompass the production of implantable devices where 3D printing can bring substantial benefits such as customization, optimization, and manufacturing of very complex geometries. The conceptual smoothness of the whole process may lead to the idea that any medical practitioner can use a 3D printer and her/his imagination to design and produce novel products for personal or commercial use. Aims Outlining how the whole process presents more than one critical aspects, still demanding further research in order to allow a safe application of this technology for fully-custom design, in particular confining attention to orthopaedic/orthodontic prostheses defined as components responding mainly to a structural function. Methods Current knowledge of mechanical properties of additively manufactured components has been examined along with reasons why the behaviour of these components might differ from traditionally manufactured components. The structural information still missing for mechanical design is outlined. Results Mechanical properties of additively manufactured components are not completely known, and especially fatigue limit needs to be examined further. Conclusion At the present stage, with reference to load-bearing implants subjected to many loading cycles, the indication of custom-made additively manufactured medical devices should be restricted to the cases with no viable alternative.