● Instrument-Free Application: The ‘pull and tighten’ mechanism allows for quick and
easy fixation without the need for additional tools, enabling a secure standard bone flap
in under a minute using just three devices.
● Radiolucency: Being metal-free, the device does not interfere with postoperative
imaging modalities such as X-rays, CT scans, or MRIs.
● High Mechanical Strength: The PEEK material provides fixation strength comparable
to traditional metallic devices, ensuring reliable stabilization of the bone flap.
● Safety and Biocompatibility: PEEK-OPTIMA™ has a proven track record of over 20
years for safety, biocompatibility, and biostability, reducing the risk of adverse reactions.
● Regulatory Approvals: The Cranial LOOP system holds CE-mark and FDA clearance,
underscoring its compliance with international medical device standards.
● Reduced Operating Time: The Cranial LOOP’s instrument-free, ‘pull and tighten’
mechanism allows for rapid bone flap fixation in under a minute, significantly reducing
procedure time compared to traditional plates and screws
