INTRODUCTION: The aim of this study was to evaluate the antimicrobial activity of an iodine-treated titanium needle we designed and manufactured for external stent fixation and its biosafety. METHODS: We prospectively performed external stent fixation with iodine-treated external fixation half nails and kerf pins in 34 limbs of 33 patients. The group included 24 males and 10 females, with a median age of 36.6 years. The preoperative diagnosis included 17 cases of limb deformity, 7 cases of pseudarthrosis, 6 cases of fracture, and 3 cases of clubfoot. A total of 154 external fixation half nails and 139 kerf pins were used in this group of cases for external brace fixation, resulting in a total of 432 pin tracts. Total white blood cells (WBC) and C-reactive protein (CRP) were measured preoperatively and postoperatively in all patients. To determine whether the iodine released by the external fixation staples/needles had an effect on the patient’s body, we also measured thyroid hormone levels in the blood. Imaging was performed regularly in all cases postoperatively. RESULTS: The mean follow-up time after surgery was 6 months. No deep infections occurred in our cases postoperatively, and only 3 cases had superficial infections. The rate of infection in the external fixation nail tract was 0.9%. All cases of external fixation nail/pin infection were not removed and healed with antibiotic treatment. Median WBC values were normal and CRP recovered to <0.3 within 3 weeks postoperatively. thyroid function tests were not abnormal. No signs of loosening of the external fixation staple/pin were detected on imaging in all cases. Discussion and conclusion: External fixation with iodine-treated titanium nails significantly reduced the incidence of nail tract infection and did not affect thyroid function. The results of this study suggest that iodine-treated titanium nails have good biosafety and are effective in preventing the occurrence of nail tract infections.