Implantable PEEK Sheet
NATUREGEN® implantable PEEK sheet
- NATUREGEN® PEEK sheet, designed to meet the specific and rigorous demands of implantable medical devices,is the medical grade long-termed implantable PEEK by Junsun medical.
- NATUREGEN® PEEK is established as being a safe, long-term implantable polymer that can meet the needs of medical device manufacturers, surgeons and patients.
| Product name | NATUREGEN® PEEK sheet |
| Grade | Implantable grade |
| Color | Natural |
| Density | 1.3g/cm3 |
| Certificate | ISO 13485 & ISO 9001 |
| Standard | ASTM F2026 & ISO 9003 |
| Size | 500*40*1000mm or customization |
ADVANTAGES
- JUNSUN medical have the PEEK polymer synthesis patent, a clean production workshop and advanced production line that meet the requirements of Good Manufacturing Practice(GMP) was built for implantable grade PEEK production.
- NATUREGEN® PEEK have passed the material characterization analysis, chemical composition testing, physical performance testing and biocompatibility test, and each test result met the requirements of ASTM F2026 and ISO 10993 which also reached the same level of international similar products.
- ISO 9001, ISO 13485 quality management system
- Complies with ASTM F2026“Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications”
- Complies with biological standards ISO 10993
- In-house ethylene oxide (EtO) sterilization
- Gamma sterilizable
- Quality assured, every time
- Traceability:complete batch and raw materials
COMPLETE BIOCOMPATIBILITY TEST REPORT
Standard |
Item |
Result |
| ISO 10993-3 | Bacterial Reverse Mutation (Ames) Study | Pass |
| Genotoxicity (In Vitro Mouse Lymphoma tk Assay ) | Pass | |
| ISO 10993-4 | Hemolysis | Pass |
| ISO 10993-5 | In Vitro Cytotoxicity | Pass |
| ISO 10993-6 | Local Effects after Implantation(Implantation in Bone） | Pass |
| ISO 10993-10 | Intracutaneous Reactivity | Pass |
| Skin Sensitization | Pass | |
| ISO 10993-11 | Acute Systemic Toxicity | Pass |
| Rat Subchronic Systemic Toxicity | Pass | |
| Pyrogen | Pass | |
| In Vitro mammalian chromosome aberration test | Pass |
PROPERTIES of PEEK SHEET
Excellent biocompatibility
NATUREGEN®PEEK can be made into an implant that integrates seamlessly with the human body, is easily compatible with the human body, and can be implanted without serious problems such as cytotoxicity, genotoxicity, or immunogenicity.Modulus similar to bone
With a bone-like modulus, NATUREGEN PEEK polymers help minimize stress shielding and stimulate bone healing.This makes it an excellent candidate for structural, load-bearing implantable devices used in spine, hip and knee replacements.
Artifact-free imaging
NATUREGEN®PEEK polymers provide artifact-free imaging and unobstructed views when using X-ray, CT and MRI imaging techniques. NATUREGEN® PEEK eliminates the risk of allergic reactions to heavy metals，so it can replace metal, ceramic and other traditional materialsAPPLICATION of PEEK SHEET
PEEK sheet is tailored to offer superior performance in a variety ofapplications including spine,sports medicine, cardiovascular, cranial-maxillo-facial,orthopaedics extremities or dental.
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