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.
_______________________________________________________________________________________________________________________________________________________________________
Properties Information | ||||||
Property | Reference Standard | Test Method | Unit | Specification | Result | |
Physical Properties | Glass Transition | ASTM F2026 | ASTM D3418 | °C | 125-165 | 147 |
Temperature, Tg | ||||||
Melt Temperature, Tm | ASTM F2026 | ASTM D3418 | °C | 320-360 | 338 | |
Recrystallization | ASTM F2026 | ASTM D3418 | °C | 260-320 | 289 | |
Temperature, Tc | ||||||
Viscosity | ASTM F2026 | ISO 11443 | Pa·s | 400-480 | 437 | |
Infrared Spectrum | ASTM F2026 | ASTM F1579 | / | See Appendix X1 | See Appendix X2 | |
Density | ASTM F2026 | ASTM D1505 | kg/m3 | 1280-1320 | 1294 | |
Chemical Properties | Total Heavy Metals (Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb, and Sn), max | ASTM F2026 | US Pharmacopeia, | ppm | <100 | <10 |
Test 233 | ||||||
Mechanical Properties | Tensile Strength at Yield (zero slope), min | ASTM F2026 | ASTM D638, Type IV, 5.08 cm/min | MPa | 90 | 105 |
Tensile Strength at Break, min | ASTM F2026 | ASTM D638, Type IV, 5.08 cm/min | MPa | 70 | 80 | |
Elongation at Break, min | ASTM F2026 | ASTM D638, Type IV, 5.08 cm/min | % | 5 | 18 | |
Flexural Strength, min | ASTM F2026 | ASTM D790 | MPa | 110 | 163 | |
Flexural Modulus, min | ASTM F2026 | ASTM D790 | GPa | 3 | 4 | |
Impact Strength, | ASTM F2026 | ISO 180 | kJ/m2 | 4 | 9 | |
Notched Izod, min | ||||||
Biological Properties | Genotoxicity | ISO 10993-3 | ISO 10993-3 | / | Negative | Negative |
Animal Intracutaneous (Intradermal) Reactivity | ISO 10993-10 | ISO 10993-10 | / | ≤1 | 0 | |
Skin Sensitization | ISO 10993-10 | ISO 10993-10 | / | ≤1 | 0 | |
Acute Systemic Toxicity | ISO 10993-11 | ISO 10993-11 | / | No Acute Systemic Toxicity | No Acute Systemic Toxicity | |
Subchronic Systemic Toxicity | ISO 10993-11 | ISO 10993-11 | / | No Subchronic Systemic Toxicity | No Subchronic Systemic Toxicity | |
local Effects After Implantation | ISO 10993-6 | ISO10993-6 | / | No obvious difference between the test sample and the control sample | No obvious difference between the test sample and the control sample | |
In Vitro Cytotoxicity | ISO 10993-5 | ISO10993-5 | / | ≤1 | 1 | |
Evaluation of Haemolytic Properties | ISO 10993-4 | ISO10993-4 | % | <5 | 1 | |
Material Mediated Pyrogens | ISO 10993-11 | ISO 10993-11 | / | No Pyrogenic Responses | No Pyrogenic Responses | |
Extractables of The Material | ISO 10993-18 | ISO 10993-18 | μg/g | The contents of Phenyl Sulfone≤300 | The contents of Phenyl Sulfone<0.09 |
_______________________________________________________________________________________________________________________________________________________________________