Purpose <p>The main objective of this study was to assess the safety and efficacy of a polymeric clamp-like device (Cranial LOOP) to fix the bone flap after a craniotomy in pediatric patients. A secondary objective was to assess the safety and efficacy of this device in children younger than 3&#xa0;years old (off-label).</p> Methods <p>Follow-up visits and CT scans from 60 pediatric patients in which the craniotomy had been fixed with Cranial LOOP were retrospectively analyzed to assess bone stability, growth, alignment and fusion, esthetic outcomes, and postoperative complications.</p> Results <p>All the registered patients had adequate bone stability, growth, and alignment and satisfactory esthetic outcomes. Most patients (90.5%) had bone fusion from 1 year after surgery. There were no related postoperative complications during the follow-up. Off-label patients had the same results in all the assessed variables as the global population.</p> Conclusions <p>Cranial LOOP is a safe and effective method to fix craniotomies in pediatric patients that allows adequate bone growth and fusion. Cranial LOOP can be safely used in children younger than 3&#xa0;years old with good results.</p>