A Winning Formula
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PEEK-OPTIMA® is an inherently pure inert material. Extensive
biocompatibility testing demonstrated no evidence of cytotoxicity,
systemic toxicity, irritation or any macroscopic reaction
response.
• 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
PEEK-OPTIMA® Biocompatibility Test
PEEK-OPTIMA polymer, provided by Invibio®, is now recognized 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 utilizes advanced CAD/CAM and 3D
printing technologies to design and manufacture the world leading
cranial implants 2.
Non-magnetic and highly translucent to X-rayCT/MRI imaging
without scattering or artifacts
Outstanding Bio-Mechnical Character
Excellent Biocompatibility
KTLK 16 Straight Two Holes Plate 16mm Long
KTLKL 18 Straight Two Holes Plate 18mm Long
KTSKL 22.1 Straight Four Holes Plate 22.1mm Long
KTSKL 24.1 Straight Four Holes Plate 24.1mm Long
KTXHL 26.6 Burr Hole Cover Diameter 26.6mm
KTXHL 28.6 Burr Hole Cover Diameter 28.6mm
KTXHL 30.6 Burr Hole Cover Diameter 30.6mm
Available sterile package for quick access and application
Arc-shaped design provides precise match with the craniumSame
operation practice as Titanium product and easy to learn
Product Code and Specification
Ease of Use
Four Holes Titanium Plate
Four Holes PEEK Plate
Four Holes Titanium Plate
(3pcs)
Four Holes PEEK Plate
(3pcs)
Yield Pressure of Cranial Model (N)Yield Pressure at 90o (N)
Outstanding Fixation Result
Better Imaging Compatibility
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 forced deformity
occurs
Safe and Steady Flexural Strength is up to four times stronger
comparing with Titanium productsSteadier performance when fixing
with bulky and uneven bone flaps
1 Resource data is quoted from FDA database2 Kontour innovative
technology in designing and manufacturing Patient-Specific Implant
was rewarded the Second Class of National Technology Award. Cert
No. 2014-F-30801-2-04-R06
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