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kontour Brochure of PEEK Sternal Fixation System

kontour Brochure of PEEK Sternal Fixation System

kontour Brochure of PEEK Sternal Fixation System

Product catalog summary
Imaging Compatibility
PEEK is a high molecular polymer known for its excellent imaging compatibility. It is non-magnetic, MRI safe, and highly translucent to X-ray, making it CT compatible without artifacts or scattering.
Biological Compatibility
PEEK exhibits excellent histocompatibility and biological characteristics. It is non-cytotoxic, non-carcinogenic, non-conductive, and resistant to hydrolysis. It can withstand 3,000 autoclave sterilizations at 134ºC, is corrosion and fatigue resistant, and shows no deformity after gamma radiation.
Bio-Mechanics Compatibility
PEEK has a bone-like modulus that minimizes stress shielding, with superior tensile strength and comparable mechanical strength to native bone.
PEEK Sternal Fixation System
PEEK-OPTIMA® polymer, provided by Invibio, is recognized globally as a high-performance biomaterial. It meets stringent in-vivo criteria, offering excellent mechanical performance, plasticity, chemical resistance, and biocompatibility. It is widely used in cardiovascular, dental, neurological, and orthopedic implants, with over 9 million implant cases worldwide.
Product Specifications
The document lists various product specifications for PEEK sternal fixation systems, including different sizes and models.
Biocompatibility Tests
PEEK-OPTIMA® has undergone extensive biocompatibility testing, showing no evidence of cytotoxicity, systemic toxicity, irritation, or macroscopic reaction. Tests include Genotoxicity, Hemolysis, Cytotoxicity, Biostability, Sensitization, Pyrogenicity, and Chemical Analysis, among others.
Bio-Mechanical Characteristics
PEEK offers outstanding bio-mechanical characteristics, exceeding the tensile strength of native bone and effectively distracting stresses during deformity. It provides a non-metallic solution for reliable and rigid sternal fixation.
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Catalog excerpts

kontour Brochure of PEEK Sternal Fixation System-1

Imaging Compatibility PEEK is a high molecule polymer with better imaging compatibility Non-magnetic and MRI safe Highly translucent to X-ray and CT compatible Biological Compatibility PEEK performs excellent histocompatiblity and biological characteristics Non-cytotoxic, non-carcinogenic, non-conductive and hydrolysis resistance Withstand 3,000 times of autoclave sterilization at 134º Corrosion resistance and fatigue resistance No deformity after gamma radiation Bio-Mechanics Compatibility Bone-like modulus helps minimize stress shielding Superior tensile strength than native bone Comparable mechanical strength to native bone High Performance Biomaterial World Leading Manufacturing Technology 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 9 million implant cases 1. Block 12, No.6, Qinling Avenue, Caotang Technology Industry Base, Xi'an High-tech Zone, Xi'an, China, 710304 Shanghai: A1509-1510, Lvdihui Center, No. 500, Yunjin Road, Xuhui District Beijing: 1109, Block A, Ritan International Trade Center, No.17, North Ritan Road, Chaoyang District PEEK Sternal Fixation System Note : 1 Resource data is quoted from FDA database Scan QR Code for details Medical Device Registration Certificate Number 20193130722 IMAGING COMPATIBLE BIOLOGICAL COMPATIBLE BIO-MECHANICS COMPATIBLE

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kontour Brochure of PEEK Sternal Fixation System-2

Excellent Imaging Compatibility Excellent Biocompatibility Non-magnetic and MRI safe Artifact-free and scattering-free Highly translucent to X-ray and CT compatible Good biological characteristics and histocompatibility Capable to sustain repeated steam, ETO sterilization and Gamma irradiation Non-cytotoxic, non-carcinogenic, non-conductive,hydrolysis resistance and corrosion resistance Test material implanted in paravertebral muscle for one year caused virtually no response-mild fibrosis, or in some cases a light fibrous capsule. There was no muscle degeneration, nor necrosis, or any other significant...

 Open the catalog to page 2
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