Overview
The document provides detailed information about the PEEK Cranial Fixation System developed by Kontour Medical, highlighting its biocompatibility, mechanical performance, and innovative design features.

Specifications and Materials
The system utilizes PEEK-OPTIMA® polymer, known for its excellent biocompatibility and mechanical properties. It is non-magnetic, highly translucent to X-rays, and does not cause scattering or artifacts in CT/MRI imaging. The material has been extensively tested for various biocompatibility standards, including cytotoxicity, genotoxicity, and pyrogenicity, among others.

Design and Technology
Kontour Medical employs advanced CAD/CAM and 3D printing technologies to create cranial implants. The system features a Dual-Rack™ design for enhanced safety and durability, and a 3D Self-Adaptive System® for better cosmetic results. The Lower-Disk design minimizes damage to the cranial bone flap.

Product Specifications
The document lists various product codes and specifications for the PEEK Cranial Clamps and Titanium Cranial Clamps, detailing dimensions and yield pressure before and after tensioning.

Ease of Use
The system is designed for ease of use with sterile packaging, a user-friendly one-step tensioning feature, and an innovative "Self-snap" design that requires no additional instruments. It offers mechanical strength comparable to artificial bone and effectively manages stress during deformities.

Certifications and Awards
The technology used in designing and manufacturing patient-specific implants has been recognized with a National Technology Award.