Polyetheretherketone (PEEK) is a high-performance engineering thermoplastic that has gained significant attention in the medical device industry, especially for implantable applications. With an elastic modulus similar to that of cortical bone, PEEK offers excellent biocompatibility, radiation permeability, and mechanical strength. These properties have made it increasingly popular in orthopedic implants, although its use is still limited in China due to reliance on imported materials. Currently, domestic production of implant-grade PEEK remains in the experimental phase, with machining from bar stock being the primary method.
At Beijing Fule Technology Development Co., Ltd., we are working to improve the processing of PEEK for orthopedic implants, such as interbody fusion cages. As shown in Figure 1, the dimensional tolerance requirements for these products are generally not very strict, except for specific grooves like the 2mm × 4mm feature. However, despite the relatively low tolerance demands, processing implant-grade PEEK presents unique challenges due to its material characteristics.
Firstly, PEEK has a slight tendency to absorb moisture. To prevent contamination during machining, strict cleanliness protocols must be followed. This means that traditional cutting fluids are not suitable. Instead, we use direct machining without any cutting fluid, which helps avoid contamination caused by water absorption. While this approach eliminates some risks, it also introduces new challenges related to heat generation during the process.
Secondly, excessive heat during machining can lead to carbonization or degradation of the material, potentially leaving toxic residues. This is particularly critical for medical implants. To address this, we carefully control cutting parameters, such as speed, feed rate, and depth of cut. Through extensive testing, we determined optimal settings that prevent coking and surface hardening, which could cause cracks in small features like φ1 mm holes.
Thirdly, surface quality is crucial for implants. Any burrs or imperfections can pose serious health risks. PEEK, like other thermoplastics, tends to produce burrs during machining. Removing them manually is time-consuming and labor-intensive, especially in complex geometries like those found in interbody fusion cages. While we currently rely on manual scraping, there are emerging technologies abroad that offer low-temperature burr removal methods without compromising surface integrity. We hope such innovations will soon become available in China.
In conclusion, while foreign manufacturers often use thermoplastic processing techniques like injection molding for PEEK implants, these methods are more cost-effective and less problematic. However, localizing the production of implant-grade PEEK would greatly benefit China's medical device industry. By improving quality and reducing costs, we aim to enhance the competitiveness of domestic medical products and ultimately serve patients better.
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