Kontour

Cranial fixation system.

PEEK-OPTIMA polymer, provided by Invibio®

Is now recognised as a high-performance biomaterial in worldwide. It is formulated to meet the most exacting in-vivo criteria and present excellent mechanical performance, plasticity, chemical resistance and biocompatibility. It is also capable to be repeatedly sterilized without impairing performance and behaves highly radiolucent CT/MRI imaging without scattering or artifacts. PEEK-OPTIMA polymer has been widely utilized in cardiovascular, dental, neurological and orthopaedic implants and globally accumulated more than 5 million implant cases 1. In conjunction with the outstanding PEEK-OPTIMA polymer performance, Kontour Medical utilises advanced CAD/CAM and 3D printing technologies to design and manufacture the world leading cranial implants 2.

PEEK PSI

Outstanding biocompatibility

Non-cytotoxic, corrosion resistance non-carcinogenic, non-conductive and hydrolysis resistance Good biological characteristics and histocompatibility Capable to sustain repeated steam, ETO sterilisation and Gamma irradiation.

Excellent bio-mechanical properties

Exceeding tensile strength to the native bone and provide better protection to the cerebrum Comparable mechanical strength to the artificial bone and capable to distract the stress effectively when deformity occurs.

 

  • Temperature Resistance:  -150° C ~ 260 ° C.
  •  Radiation Resistance:No deformity after Gamma radiation, corrosion resistance and fatigue durability.
  • Applicable for Autoclave, Gamma, Ethylene oxide.
  • (ETO) sterilization methods.
  • Higher strength comparable to the nature bone and capable to effectively protect the brain tissues.
  • Similar mechanical properties to the natural bone and capable to disperse the stress when deformity occurs.

Improved comfort after implant

Light weight and improved comfort after implant.
Good thermal insulation to eliminate malaise  due to the different temperature.

Precisely reconstruct natural contour

  • Precisely match the natural contour and convenient to implant.
  • Literature proves clinical complications rate of PEEK implant comparable to the Titanium implant.
  • CAD/CAM technology allows to restore the defect models and reconstruct  the natural contour of the brain.

Bio-Mechanical Properties chart

“Elasticity modulus” normally also known as Young’s Modulus, is a number that measures an object or substance’s resistance to being deformed elastically.

Modulus Chart

Stress load test result for Titanium and PEEK implant:
PEEK has more similar modulus to the natural bone and it provides better protection for the brain to avoid the damages.

Outstanding imaging compatibility

  • Non-Magnetic and highly translucent to X-ray.
  • CT/MRI imaging without scattering or artifacts.

Material

Infection rate of different implant materials

Peek Clamp

Excellent Biocompatibility

PEEK-OPTIMA® is an inherently pure inert material. Extensive biocompatibility testing demonstrated no evidence of cytotoxicity, systemic toxicity, irritation or any macroscopic reaction response.

Outstanding biomechanical character

Exceeding tensile strength to the native bone and provide better protection to the cerebrum Comparable mechanical strength to the artificial bone and capable to distract the stress effectively when deformity occurs.

Biocompatibility Test

  • Genotoxicity ISO 10993-3.
  • Hemolysis (Extract) ISO 10993-4
  • Cytotoxicity ISO 10993-5.
  • Biostability Local Effects of
  • Implantation ISO 10993-6.
  • Sensitization ISO 10993-10.
  • Pyrogenicity ISO 10993-11.
  • Chemical Analysis ISO 10993-18.
  • USP Plastic Class VI Systemic
  • Toxicity Study USP Plastic Class VI
  • Intracutaneous Toxicity.

Steady reliable performance

Dual-RackTM design secures the safety and durability.

Ease of use

  • Sterile packaging for rapid application.
  • User-friendly feature with one-step tensioning only.
  • Easy to remove for second operation.
  • Innovative and safe “Self-snap” design requires no other instrument.

3D adaptive system

Excellent Cosmetic Result

  • Excellent Cosmetic Result. 
  • More reliable and safe safer operation.
  • Still Lower-Disk design avoids second damages on the cranial bone flap and bone fragment.

Outstanding imaging compatibility

Non-magnetic and highly translucent to X-ray CT/MRI imaging without scattering or artifacts.

TITANIUM

Titanium plate

Variety of selection to meet the clinical needs.

 

  • Outstanding biocompatibility and CT/MRI compatible.
  • Excellent ductility and plasticity.
  • Unique countersunk design to ensure the low-profile cosmesis. 

Sterile kit pack

  • Rapid and ease of use for emergency cases.
  • Well protection for the plates and screw tips.

Sterile anvil plate

  • Avoid screw tips worn-out prior to use.
  • Easy to access and apply.

Sterile kit container

  • All-in-one sterile pack for standard craniotomy closure.
  • Easy-to-use slide-out and transparent lid design for well organisation and recognition.

Titanium mesh

  • Excellent ductility and rigidity.
  • Outstanding biocompatibility and CT/MRI compatible.
  • Unique countersunk design to ensure the low-profile cosmesis.
  • Variety of selection for 2D & 3D  specification.
  • Digital Reconstruction Technology capable to derive the patient CT data obtained from the hospital and regenerate the anatomical skull structures and implant models.
  • Better safety and reliable.
  • Ease of use and rapid implant.

Customized titanium plate

  • Available customized service according to the specific clinical needs

PEEK PLATE

Excellent Biocompatibility

PEEK-OPTIMA® is an inherently pure inert material. Extensive biocompatibility testing demonstrated no evidence of cytotoxicity, systemic toxicity, irritation or any macroscopic reaction response.

Excellent biomechanical character

Exceeding tensile strength to the native bone and provide better protection to the cerebrum Comparable mechanical strength to the artificial bone and capable to distract the stress effectively when deformity occurs.

Biocompatibility Test

  • Genotoxicity ISO 10993-3.
  • Hemolysis (Extract) ISO 10993-4
  • Cytotoxicity ISO 10993-5.
  • Biostability Local Effects of
  • Implantation ISO 10993-6.
  • Sensitization ISO 10993-10.
  • Pyrogenicity ISO 10993-11.
  • Chemical Analysis ISO 10993-18.
  • USP Plastic Class VI Systemic
  • Toxicity Study USP Plastic Class VI
  • Intracutaneous Toxicity.

Incredible fixation result

Safe and Steady.

Flexural Strength is up to four times stronger comparing with Titanium products Steadier performance when fixing with bulky and uneven bone flaps.

Ease of use

  • Available sterile package for quick access and application.
  • Arc-shaped design provides precise match with the cranium.
  • Same operation practice as Titanium product and easy to learn.

Outstanding imaging compatibility

Non-magnetic and highly translucent to X-ray CT/MRI imaging without scattering or artifacts.

CALL

Office: +27 (0)87 150 2806

Fax: +27 (0)86 260 1821