![]() The FDA mandates that any medical material that comes into direct or indirect contact with human tissue and fluids must maintain mechanical and molecular integrity.Īnything touching or interacting with human tissue and bone must be both biocompatible and biostable for a patient. When it comes into contact with human tissue and fluids, it’s compatible with the environment and will not incur adverse effects.īiostability – The ability of a material to maintain its physical and chemical integrity after implantation into living tissue. To differentiate, let’s briefly discuss biocompatibility versus biostability.īiocompatibility – The biological requirements of a biomaterial or biomaterials used in a medical device. PEEK displays excellent biocompatibility and biostability as a performance medical-grade material. The Biocompatibility and Biostability of PEEK PEEK is now an established biomaterial that will only continue to expand. By 2007 that number had increased to 402,000. In the United States, spine fusion is one of the leading surgeries for patients who suffer from chronic neck and back pain that does not respond to preliminary treatments.Īccording to Orthopedic Design & Technology, around 215,000 Americans underwent spine fusion procedures in 1997. Since then, PEEK has only expanded as a performance biomaterial for instrumented spine surgery. The Future of PEEK Beyond Spinal Implants It was implanted in 1999 and made with PEEK-OPTIMA™ from Invibio Biomaterial Solutions. An intervertebral fusion cage was the first piece of spinal instrumentation that had been made with PEEK rather than metal. Laboratory studies during the 1990s confirmed that PEEK implants had the needed combination of wear, strength, creep, and fatigue resistance to replace the metallic biomaterials in spinal implants. Due to its relative inertness, radiolucency and chemical resistance, PEEK has had the greatest clinical impact in spine implant design. Since the 1980s, Polyaryletherketones (PEEK) have been utilized as biomaterials in trauma, orthopedic, and spinal implants. Additionally, clinical studies of PEEK for cervical fusion have revealed its advantages over titanium or cadaver bone.Īs this material continues to gain traction in the orthopedic industry, it has shown superior qualities over stainless steel and titanium for biocompatibility, radiolucency, and durability.Ī Brief History of PEEK in Orthopedic Surgery ![]() In orthopedics, PEEK has been used for intervertebral cages, posterior & anterior instrumentation, and standard lumbar fusion. Carbon-reinforced PEEK is similar in strength to cortical bone, making it an attractive biomaterial for spinal fusion surgery, and reduce stress shielding. ![]() It comes in different versions ranging from unfilled grades with varying molecular weight, to those with image-contrast and carbon fiber-reinforcement grades for demanding medical treatments inside the body or in the operating room. Medical-grade Polyetheretherketone (PEEK) is a radiolucent high-performance polymer alternative to metallic biomaterials. Why PEEK Plastic Material Biocompatibility Is the Standard in Orthopedic Surgery ![]()
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