Specialty Polymers for Orthopedics
The orthopedic industry is responding to multiple demands: significant increases in global ageing populations; major advances in state-of-the art surgical practices; the high cost of implants and surgery induced health risk factors. The advanced materials available from Solvay introduce a wide variety of solutions which can improve design, performance, cost as well as reduce the risk of hospital acquired infections. With over 30 years of experience as the leading materials supplier for sophisticated implantable devices and surgical instruments, Solvay continues to provide the orthopedic industry with the largest selection of high-performance specialty polymers.
Our broad portfolio of biocompatible plastics offers OEMs a wide selection of materials with the highest level of versatility for both implantable devices and surgical instruments, cases and trays. Solvay specialty polymers for orthopedics exceed the industry performance standards and outperform traditional metallic components with outstanding impact strength, superb chemical resistance and excellent sterilization compatibility for the most advanced healthcare instruments.
Solvay’s specialty thermoplastics are tested for quality under ISO 10993:1 and the highest industry standards to ensure maximum performance and reliability. Our specialty polymers offer advanced material solutions in a range of orthopedic applications such as: orthopedic surgery kits; fixation devices; fusion devices; trauma plates; hip and knee replacements; and tibial, femoral and glenoid trials.
Single-Use Orthopedic Instruments
Solvay’s specialty polymers are equipped with advanced properties that improve manufacturing and performance standards across an array of single-use orthopedic applications. These rigid, high-quality plastics offer metal-like tensile strength for use in tools such as curettes, inserters, needle holders, forceps, lids and surgery kits. Specifically, Ixef® PARA (polyarylamide) and Udel® PSU (polysulfone) provide superior mechanical performance and cost-effective sterilization methods for orthopedic single-use instruments.
Reusable Orthopedic Instruments
Solvay’s high-performance specialty polymers provide orthopedic reusable instruments with outstanding reliability, resilience and longevity. Solvay specially formulates their wide selection of polymers with unmatched tensile strength and chemical resistance to easily withstand repeat-cycle sterilization and long-term use. Accordingly, these medical-grade plastics tolerate the extremely high temperatures and harsh environments of steam autoclaving without any significant loss of mechanical properties and performance abilities. Radel® PPSU, AvaSpire® PAEK and KetaSpire® PEEK are essential polymers for orthopedic applications such as handles, knobs, grips, trials, cases, trays, and retractors.
Improved Orthopedic Implants
Orthopedic implants, such as spinal cages or trauma plates, require a modulus similar to bone to mimic the natural body and fatigue resistance that enables longevity. Solvay’s Zeniva® PEEK (polyetheretherketone) offers outstanding tensile strength, creep resistance and a density almost identical to cortical bone to exceed these requirements and make it a viable alternative material for use in load-bearing structures, fusions and other orthopedic implants. Additionally, this biostable thermoplastic is radiolucent, which helps facilitate post-operative medical imaging.
Chemical Resistance and Sterilization Compatibility
As gamma and steam sterilization exposes equipment to extremely harsh environments, the materials used in orthopedic devices must provide exceptional chemical resistance to maintain its optimal performance and mechanical integrity for extended use and repeat-cycle sterilization. Solvay’s specialty polymers for orthopedics have outstanding chemical resistance and high-heat tolerance to maintain their physical and performance properties in the harshest sterilization environments.
Compatibility with sterilization methods
Test Standards and Best Practices
Solvay’s portfolio of specialty polymers for orthopedics is tested for biological safety and quality under the highest industry standards to ensure optimal performance. This family of unparalleled thermoplastics meets USP Class VI testing standards both before and after gamma and steam sterilization and is tested under ISO 10993:1 for biocompatibility. All of our data is made available to our customers through our FDA Master Access File. Accordingly, we confidently recommend our materials for a full range of orthopedic applications.
Specialty Polymers for Orthopedics
Radel® PPSU (polyphenylsulfone) delivers unparalleled chemical resistance, excellent sterilization compatibility for orthopedic applications and the highest performance in its class of comparable polymers. This strong, amorphous thermoplastic offers extremely high temperature tolerance and excellent hydrolytic stability. Accordingly, Radel® PPSU maintains its mechanical and performance properties through up to 1,000 steam-sterilization cycles and also supports an array of cleaning and disinfection methods. Additionally, Radel® PPSU provides reusable orthopedic devices and instruments with tremendous strength and the ability to tolerate significant impact without cracking or breaking. Solvay tests this high-performance specialty polymer under USP Class VI testing to ensure the preservation of its properties following repeat-gamma sterilization. Radel® PPSU is available in a variety of grades and colors, both transparent and opaque.
Radel® PPSU is an ideal specialty polymer for a variety of reusable orthopedic instruments, such as sterilization tray lids, tibial trials, acetabular materials and medical tubing.
Ixef® PARA (polyarylamide) is a rigid specialty polymer that provides dimensional stability and metal-like strength for single-use orthopedic instruments. This high performance specialty polymer combines an outstanding surface gloss with excellent tensile and flexural strength. Additionally, this sophisticated thermoplastic withstands high-energy gamma radiation and bulk sterilization without significant changes to its original properties to support a multitude of cost-saving and effective cleaning methods. Solvay offers Ixef® PARA in an array of gamma-stabilized (GS) colors to facilitate differentiation in instrument sizes and types and present OEMs with unique branding opportunities. These GS resins demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity when tested under ISO 10993:1 for biocompatibility.
Ixef® PARA is an optimal specialty polymer for several single-use orthopedic applications and functions exceptionally well in spinal surgery kits that enhance operating room efficiency and eliminate reprocessing costs.
AvaSpire® PAEK (polyaryletherketone) is a family of tailored high-performance polyketones that offer higher ductility and toughness in comparison to other grades of PEEK and other polymers. This advanced thermoplastic also offers superior chemical resistance and mechanical properties that can be reinforced by glass or carbon fiber. AvaSpire® PAEK combines these properties with excellent aesthetics and colorability to deliver an array of grades that outperform other polymers of its class. Additionally, AvaSpire® PAEK’s unmatched stiffness, strength and chemical resistance provide outstanding performance at up to 30% lower cost than other PEEK materials used in reusable instruments.
AvaSpire® PAEK is used in several orthopedic and surgical applications such as cases, trays, knobs, handles and grips. This high-performance thermoplastic is available in a variety of grades that can be customized, tailored and reinforced with glass or carbon fiber.
KetaSpire® PEEK (polyetheretherketone) is part of Solvay’s line of ultra high-performance materials used for orthopedic devices with short-term exposure to bodily tissues and fluids. This specialty thermoplastic displays a top-notch combination of fatigue and chemical resistance and can operate at higher temperatures than comparable polymers. Additionally, KetaSpire® PEEK provides orthopedic instruments with high purity and improved toughness. This sophisticated material is both steam sterilizable and gamma stable under USP Class VI compatibility testing. These outstanding properties enable KetaSpire® PEEK to replace metal in orthopedic applications and severe end-use environments. KetaSpire® PEEK is available in both high and low viscosity grades, as well as glass and carbon fiber reinforced grades.
KetaSpire® PEEK is used in various orthopedic applications such as handles, knobs and grips. Advanced grades of KetaSpire® PEEK deliver unparalleled chemical resistance and mechanical durability required for more demanding, reusable structural applications.
Udel® PSU (polysulfone) is a high-performance specialty polymer with an outstanding combination of strength, toughness and thermal stability. The properties of this rigid, semi-tough, transparent thermoplastic provides single-use orthopedic applications with enhanced stiffness and excellent biocompatibility. Additionally, Udel® PSU resins are tested for gamma sterilization compatibility under USP Class VI Testing and maintain its mechanical and structural integrity when exposed to oxidizing agents, high heat, steam or other sterilization tactics.
Udel® PSU excels in fluid handling orthopedic components and applications such as membranes, heart valve sizers, retractors and lids.
Zeniva® PEEK (polyetheretherketone) is a high-performance specialty polymer that offers extreme toughness and reliability for use in structural, load-bearing orthopedic devices. This sophisticated, biostable plastic has twice the strength of unmodified PEEK and serves as a comparable or better-performing alternative to metal components. Additionally, Zeniva® PEEK can be carbon fiber-reinforced to deliver excellent fatigue and creep resistance and offers manufacturers the capability to produce arthroplasty materials with smaller designs for reduced intrusiveness. Unlike implantable metals, this biocompatible polymer helps artificial joint materials to minimize bone density reduction by continuing to simulate normal stress on surrounding bone tissue. Additionally, the radiolucency of Zeniva® PEEK offers exceptional visualization of implants when using X-ray, CT scan, MRI and other imaging methods. Solvay tests Zeniva® PEEK to ensure its compatibility with a full range of applicable sterilization methods.
The strength, modulus, chemical inertness and structural properties of Zeniva® PEEK support a multitude of orthopedic applications. Zeniva® PEEK is commonly used in Suture Anchors, bone screws, spinal cage materials, tibial and femoral tray components, total knee arthroplasty, hip replacements, plastic trauma plates and fasteners.