What is a medical grade PEEK
The synthesis of PEEK materials requires the use of fluorone, phenol monomer raw materials and diphenylsulfone and other catalysts. There are a large number of monomers, toxic additives and various by-products in the synthesized PEEK raw materials. These substances have great toxicity to the human body, and PEEK raw materials need to be further purified and its residual impurities removed before they can be used as medical raw materials. Medical grade PEEK materials can be divided into general medical grade PEEK and implant grade PEEK according to their purity and material properties.
General medical PEEK: PEEK material of this grade is currently widely used in external fixation devices in contact with the human surface (such as limb fixed position orthopedic stents), short-term interventional catheters, pump parts of various circulation equipment, and non-implanted consumables such as oral Malonbridge stents. This kind of application scenario generally requires PEEK materials to have certain biological safety, such as no cytotoxicity, no sensitization, no irritation or intradermal reaction, and should also have the relevant physical and chemical properties required for the product characteristics.
Implant grade PEEK: As the name suggests, PEEK materials that can be used for the preparation of “implanted devices” are called implantable PEEK materials. These materials are often used in orthopedic implant consumables (such as interbody fusion cages, ligament repair anchors, and joint interface screws), neurosurgical prostheses (such as artificial skull and maxillofacial bones), and cardiovascular products (such as heart valves and cardiac pacemaker shells). Some manufacturers are using modified PEEK materials for the preparation of dental implants, traumatic bone plates and other products with high mechanical properties.
In addition to meeting the biological safety of general medical grade PEEK, implant grade PEEK should also meet more stringent biocompatibility requirements, such as systemic toxicity, genotoxicity, carcinogenicity, blood compatibility, and implantation reaction, and also meet the requirements of ⟪ASTM F2026 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implantapplications ⟫
The manufacture of high quality PEEK requires precise manufacturing techniques. Junsun Medical uses a strict process to produce its PEEK granule, bars, 3D printed filaments,sheets and other medical implant materials.
