Introduction
The PEEK Cranial Fixation System is a medical device designed for cranial implants, utilizing PEEK-OPTIMA® polymer, known for its high performance and biocompatibility. This document outlines the specifications, biocompatibility tests, and advantages of the system.

Material Specifications
PEEK-OPTIMA® is a pure, inert material with extensive biocompatibility testing, showing no cytotoxicity, systemic toxicity, irritation, or macroscopic reaction. It meets various ISO standards, including genotoxicity, hemolysis, cytotoxicity, and more. It is recognized globally as a high-performance biomaterial.

Product Features

• Non-magnetic and highly translucent to X-ray, CT/MRI imaging without scattering or artifacts.
• Excellent biomechanical character and biocompatibility.
• Available in various sizes and designs, including straight plates and burr hole covers.
• Arc-shaped design for precise cranial matching.
• Comparable mechanical strength to artificial bone, providing better protection and stress distribution.

Ease of Use
The system is designed for ease of use, with sterile packaging for quick access and application. It follows the same operational practices as titanium products, making it easy to learn.

Performance and Safety

• Exceeds tensile strength of native bone, offering better protection to the cerebrum.
• Flexural strength is up to four times stronger than titanium products.
• Provides steadier performance when fixing with bulky and uneven bone flaps.

Technological Advancements
Kontour Medical employs advanced CAD/CAM and 3D printing technologies to design and manufacture these implants, recognized with a National Technology Award.

Conclusion
The PEEK Cranial Fixation System offers a robust, biocompatible solution for cranial implants, with superior imaging compatibility and mechanical strength, making it a preferred choice in medical applications.