Implantable PEEK Granule
Medical Implantable PEEK Granule
- NATUREGEN® is the brand of Junsun Medical implantable polyetheretherketone granule
- Produced by Junsun Medical，the medical implantable granules have medium fluidity and can be processed by injection molding or machining.
- With excellent biocompatibility,PEEK Granule meets the ASTM F 2026 and ISO 10993 standards .
- PEEK Granule is the best raw materials for implantable peek (polyetheretherketone) rods and implantable peek plates,which can be processed into a variety of implantable medical devices.
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Color
Natural
Density
1.28g/cm3-1.32g/cm3
Certificate
ISO 13485 & ISO 9001
Standard
ASTM F2026 & ISO 9003
Processing method
Injection molding or machining
Application
Long -term Medical Device
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| Color | Natural |
| Density | 1.28g/cm3-1.32g/cm3 |
| Certificate | ISO 13485 & ISO 9001 |
| Standard | ASTM F2026 & ISO 9003 |
| Processing method | Injection molding or machining |
| Application | Long -term Medical Device |
Natural, unfilled NATUREGEN® peek is characterized by its high strength,extreme resistance to hydrolysis and resistance to the effects ofionizing radiation. Therefore, NATUREGEN® peek can be repeatedly sterilized using conventional gamma irradiation, steam and ethylene oxide without significant deterioration of mechanical properties.
Property |
Test Method |
Result |
| Genotoxicity | ISO 10993-3 | Negative |
| Animal Intracutaneous(ntradermal)Reactivity | ISO 10993-10 | 0 |
| Skin Sensitization | ISO 10993-10 | 0 |
| Acute Systemic Toxicity | ISO 10993-11 | No Acute Systemic Toxicity |
| Subchronic Systemic Toxicity | ISO 10993-11 | No Subchronic Systemic Toxicity |
| local Effects After Implantation | ISO 10993-6 | No obvious difference between the test sample andthe control sample |
| In Vitro Cytotoxicity | ISO 10993-5 | 1 |
| Evaluation of Haemolytic Properties | ISO 10993-4 | 1 |
| Material Mediated Pyrogens | ISO 10993-11 | No Pyrogenic Responses |
| Extractables of The Material | ISO 10993-18 | The contents of Phenyl Sulfone<0.09 |
Application of PEEK Gruangle
NATUREGEN® peek granule has excellent biocompatibility , and is the best raw material for anchors, interfacial screws and sternal fixation bands The PEEK Anchor provides excellent performance over the healing period in rotator cuff surgery. The Anchor is made of Polyetheretherketone (PEEK) In sports medicine, NATUREGEN® peek granule is an excellent material for fixation such as suture anchors and bone screws to hold ligaments and tendons to bone for long periods of time
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