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PEEK Medical

                

                
  • Implantable PEEK Pellet
  • Implantable PEEK Pellet

Implantable PEEK Pellet

ARK-BioPEEK implantable PEEK pellets are high-purity, medical-grade polymer resins engineered for extrusion and injection molding processes. They deliver excellent biocompatibility, mechanical strength, chemical resistance, and sterilization compatibility for manufacturing implantable medical devices.
BIOMATERIAL PROPERTY

ARK-BioPEEK implantable PEEK pellets represent a premium medical-grade polyetheretherketone resin specifically formulated for extrusion and injection molding of implantable medical devices. Manufactured under stringent quality controls and certified to meet ASTM F2026 and FDA biocompatibility standards, these pellets provide a reliable raw material solution for medical device manufacturers seeking high-performance polymers for surgical implants, orthopedic devices, spinal cages, and dental applications.


Designed for use in advanced extrusion and injection molding processes, ARK-BioPEEK pellets exhibit excellent melt flow characteristics and consistent viscosity, enabling the production of complex geometries with tight tolerances and superior surface finish. The material’s outstanding mechanical properties include high tensile strength, flexural modulus, and fatigue resistance, ensuring long-term durability and structural integrity in demanding physiological environments.


ARK-BioPEEK offers exceptional chemical resistance to bodily fluids, sterilization agents, and cleaning solvents, maintaining performance after repeated sterilization cycles including autoclave, gamma radiation, and ethylene oxide. Its thermal stability supports continuous use at elevated temperatures around 260°C, making it suitable for various sterilization and processing methods.


Key Advantages

Certified Biocompatibility: Complies with ASTM F2026, USP Class VI, and FDA regulations for implantable medical polymers.

Optimized for Medical Manufacturing: Tailored melt viscosity and flow for extrusion and injection molding of precision implant components.

Superior Mechanical Strength: High tensile and flexural properties for reliable implant performance.

Chemical & Sterilization Resistance: Maintains integrity in harsh chemical and sterilization environments.

Consistent Quality & Purity: Manufactured under ISO 13485-compliant cleanroom conditions to ensure traceability and quality.


Widely used in the production of spinal implants, orthopedic fixation devices, dental prosthetics, and other implantable medical components, ARK-BioPEEK pellets enable manufacturers to deliver safe, durable, and biocompatible medical devices that improve patient outcomes.


Choose ARK-BioPEEK implantable PEEK pellets for advanced extrusion and injection molding applications requiring the highest standards of medical-grade polymer performance and reliability.


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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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