LABORATORY-BASED EVALUATION OF GENOTOXIC POTENTIAL OF COMMERCIAL POLYAXIAL PEDICLE SCREWS

Biocompatibility, which shows the compatibility between the host and the biomaterial, is very important for the reliability of a biomaterial. It is a must for a newly produced biomaterial to meet the biocompatibility criteria, which are bound to certain rules by international organizations. One of the criteria of biocompatibility is genotoxicity. In this study, it was aimed to evaluate the genotoxicity of a commercial polyaxial pedicle screw in vitro. For this purpose, in vitro micronucleus test and bacterial reverse mutation test were performed. Extraction method was used for both tests. When the obtained results were compared statistically, it was concluded that the tested biomaterial was not genotoxic. Biocompatibility criteria determined by the International Standards Organization (ISO 10993-1, 2018).