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PEEK Medical

                

                
  • PEEK Filament Implanted Medical Grade for 3D Printing
  • PEEK Filament Implanted Medical Grade for 3D Printing
  • PEEK Filament Implanted Medical Grade for 3D Printing

PEEK Filament Implanted Medical Grade for 3D Printing

ARK-BioPEEK medical grade PEEK filament is a high-performance, biocompatible material specially formulated for 3D printing implantable medical devices and surgical instruments. It offers excellent chemical resistance, sterilizability, and mechanical strength for reliable, patient-specific solutions.

BIOMATERIAL PROPERTY

PEEK Filament Implanted Medical Grade for 3D Printing


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ARK-BioPEEK medical grade PEEK filament is an advanced thermoplastic filament designed for additive manufacturing of implantable medical devices and surgical tools using professional fused filament fabrication (FFF) 3D printers. Produced under stringent cleanroom conditions and quality management systems, this filament meets international medical standards such as ASTM F2026, ISO 10993, and USP Class VI, ensuring biocompatibility and safety for long-term implantation.


The filament exhibits outstanding mechanical properties including high tensile strength, impact resistance, and dimensional stability, enabling the production of durable, precise, and customized implants such as spinal cages, cranial plates, dental prosthetics, and orthopedic devices. Its excellent chemical resistance protects against bodily fluids, acids, and solvents, while compatibility with sterilization methods like gamma radiation, autoclaving, and ethylene oxide ensures clinical readiness.


ARK-BioPEEK filament also offers radiolucency, allowing clear medical imaging without interference, and low outgassing to maintain a contamination-free environment during manufacturing and implantation. The filament’s thermal stability supports continuous use at elevated temperatures up to 260°C, making it suitable for demanding medical applications.


By leveraging ARKPEEK medical grade PEEK filament, healthcare providers and manufacturers can produce patient-specific implants and surgical tools with reduced lead times and costs compared to traditional manufacturing methods, while maintaining the highest standards of quality and safety.


Key Benefits

Certified biocompatibility and implant-grade quality

High mechanical strength and durability

Excellent chemical and sterilization resistance

Radiolucent for superior imaging compatibility

Precision 3D printing for customized medical devices

Manufactured in ISO 13485 certified cleanroom environments


Widely used in orthopedic, dental, craniofacial, and trauma applications, ARK-BioPEEK filament empowers innovation in personalized medicine and advanced surgical solutions.


Choose ARKPEEK medical grade PEEK ARK-BioPEEK filament for reliable, high-performance, and customizable 3D printed medical implants and devices.


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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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