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Since2008 | CHINA PEEK STANDARD MAKER

PEEK Medical

                

                
  • Medical PEEK Material Rod Implant PEEK Bar
  • Medical PEEK Material Rod Implant PEEK Bar
  • Medical PEEK Material Rod Implant PEEK Bar

Medical PEEK Material Rod Implant PEEK Bar

Medical-grade, Biocompatible PEEK Polymer Materials

Implantable PEEK rods have shown remarkable felicities over typical biomedical implants such as metallic alloys, ceramics, and polyethylenes. PEEK is now used to design medical implants in joint replacement systems, spine implants, and cages in vertebral fusion surgeries.

Our wide range of biocompatible polymer materials and compounds are each designed to meet the specific and rigorous demands of implantable medical devices. PEEK materials are tailored to offer superior performance in a variety of applications including spine, orthopedic, trauma, dental and specialty devices. Innovative PEEK materials and our in-depth manufacturing knowledge combined with application expertise supports medical device companies to bring leading edge devices to market and open up new areas of growth. 


BIOMATERIAL PROPERTY

ARKPEEK medical grade PEEK ARK-BioPEEK rods and bars are high-performance, implantable-grade polyetheretherketone materials specifically formulated for precision machining of custom medical devices and implants. Manufactured to meet stringent biocompatibility standards such as ISO 10993 and ASTM F2026, these rods are ideal for applications requiring long-term contact with bodily tissues and fluids, including orthopedic implants, spinal cages, dental prosthetics, and trauma devices.


The implantable ARKPEEK rods exhibit outstanding mechanical strength, toughness, and stiffness with a flexural modulus closely matching cortical bone, reducing stress shielding and promoting better patient outcomes. Their excellent chemical resistance ensures durability against bodily fluids, cleaning agents, and sterilization processes including steam autoclaving, ethylene oxide, and gamma radiation, without degradation of physical or biocompatible properties.


Available in a wide range of diameters and lengths, ARKPEEK rods facilitate efficient machining with minimal material waste and tight dimensional tolerances, supporting complex geometries and high-precision medical components. The material’s radiolucency enables clear imaging via X-ray, CT, and MRI, aiding post-operative assessment without interference.


Key Benefits

Certified Biocompatibility: Complies with ISO 10993 and ASTM F2026 for implantable medical devices.

Superior Mechanical Performance: High tensile strength, fatigue resistance, and modulus similar to bone.

Chemical & Sterilization Resistance: Maintains integrity after repeated sterilization cycles.

Radiolucent: Compatible with medical imaging techniques.

Customizable Sizes: Available in various diameters and lengths to suit machining needs.


Widely used in the manufacture of spinal implants, joint replacements, dental devices, and trauma fixation systems, ARKPEEK implantable PEEK rods offer medical device manufacturers a reliable, high-quality polymer solution that meets rigorous regulatory and functional requirements.


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Properties Information
PropertyReference StandardTest MethodUnitSpecificationResult
Physical PropertiesGlass TransitionASTM F2026ASTM D3418°C125-165147
Temperature, Tg
Melt Temperature, TmASTM F2026ASTM D3418°C320-360338
RecrystallizationASTM F2026ASTM D3418°C260-320289
Temperature, Tc
ViscosityASTM F2026ISO 11443Pa·s400-480437
Infrared SpectrumASTM F2026ASTM F1579/See Appendix X1See Appendix X2
DensityASTM F2026ASTM D1505kg/m31280-13201294
Chemical PropertiesTotal Heavy Metals (Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb, and Sn), maxASTM F2026US Pharmacopeia,ppm<100<10
Test 233
Mechanical PropertiesTensile Strength at Yield (zero slope), minASTM F2026ASTM D638, Type IV, 5.08 cm/minMPa90105
Tensile Strength at Break, minASTM F2026ASTM D638, Type IV, 5.08 cm/minMPa7080
Elongation at Break, minASTM F2026ASTM D638, Type IV, 5.08 cm/min%518
Flexural Strength, minASTM F2026ASTM D790MPa110163
Flexural Modulus, minASTM F2026ASTM D790GPa34
Impact Strength,ASTM F2026ISO 180kJ/m249
Notched Izod, min
Biological PropertiesGenotoxicityISO 10993-3ISO 10993-3/NegativeNegative
Animal Intracutaneous (Intradermal) ReactivityISO 10993-10ISO 10993-10/≤10
Skin SensitizationISO 10993-10ISO 10993-10/≤10
Acute Systemic ToxicityISO 10993-11ISO 10993-11/No Acute Systemic ToxicityNo Acute Systemic Toxicity
Subchronic Systemic ToxicityISO 10993-11ISO 10993-11/No Subchronic Systemic ToxicityNo Subchronic Systemic Toxicity
local Effects After ImplantationISO 10993-6ISO10993-6/No obvious difference between the test sample and the control sampleNo obvious difference between the test sample and the control sample
In Vitro CytotoxicityISO 10993-5ISO10993-5/≤11
Evaluation of Haemolytic PropertiesISO 10993-4ISO10993-4%<51
Material Mediated PyrogensISO 10993-11ISO 10993-11/No Pyrogenic ResponsesNo Pyrogenic Responses
Extractables of The MaterialISO 10993-18ISO 10993-18μg/gThe contents of Phenyl Sulfone≤300The contents of Phenyl Sulfone<0.09


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TAGS: PEEK Medical

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