Usages

Main Applications and Usages of Syensqo Implantable Devices

Syensqo’s specialty biomaterials meet and exceed the highest standards of biological safety, quality, and performance demanded by medical device OEMs worldwide. Designed for orthopedic, spinal, cardiovascular, and other implantable applications, our Solviva® Biomaterials portfolio provides a proven combination of biocompatibility, chemical resistance, sterilization durability, and radiolucency.

All materials are produced in our ISO 13485 and cGMP-compliant facility in Georgia, USA, and validated in ISO 10993 laboratories. Hundreds of regulatory approvals have been successfully obtained across the USA, Europe, China, and beyond.
 

Orthopedic Implants

Orthopedic implants such as trauma plates, spinal cages, and fixation components require materials that deliver bone-like mechanical strength, imaging transparency, and long-term biocompatibility.
Syensqo’s Zeniva® PEEK, part of the Solviva® line of biomaterials, offers a modulus close to that of cortical bone, helping minimize stress shielding and maintain long-term bone density.

Key benefits include:

• Bone-like modulus – reduces stress shielding and supports natural load transfer.
• Radiolucency – transparent to X-ray, CT, and MRI for clear visualization of implants.
• Proven performance – validated under ISO 10993 and cGMP standards.

Spinal Cage Applications

Syensqo’s Zeniva® PEEK is widely used in lumbar fusion cages, enabling effective fusion of adjacent vertebrae.

The material’s combination of high fatigue strength, creep resistance, and toughness makes it an ideal alternative to titanium and stainless steel—achieving the performance required for demanding spinal and orthopedic load-bearing environments.

Cardiovascular Implants and Access Ports

Eviva® PSU is used in cardiovascular applications such as pacemaker housings and access ports, where transparency and processability are key. The natural transparency of Eviva® PSU allows visual inspection of internal components, while its excellent biocompatibility and sterilization resistance support long-term implantation.

Other Implantable Devices

Syensqo’s implantable-grade polymers have also been used in neurostimulation housings, brain shunts, hearing aids, and dental implants. Their combination of processability by injection molding, mechanical toughness, and biocompatibility make them ideal for diverse permanent and semi-permanent implant devices.

Biocompatibility and Biological Testing

All Syensqo implantable-grade polymers are rigorously tested according to ISO 10993 to ensure biological safety and tissue compatibility.

Our testing program covers:

• Cytotoxicity
• Sensitization and irritation
• Genotoxicity
• Implantation
• Hemolysis and pyrogenicity

These results confirm the non-cytotoxic, non-sensitizing, and non-irritant properties of our Solviva® biomaterials, supporting their use in direct and long-term tissue contact.

Sterilization and Chemical Resistance

Repeated sterilization is one of the toughest challenges for medical polymers. Syensqo’s materials maintain excellent mechanical integrity and chemical stability even after hundreds or thousands of sterilization cycles.

Sterilization Compatibility Overview

^{(1) Veradel® HC PESU is compatible with high-energy gamma radiation, though ductility may be reduced}

These polymers are also resistant to harsh chemical environments, ensuring dimensional stability and retention of physical properties over multiple sterilization and cleaning cycles.

Reusable and Single-Use Instrument Applications

In addition to implants, Syensqo’s polymers are widely used for single-use and reusable surgical instruments such as curettes, inserters, needle holders, and forceps.

• Single-Use Instruments: Ixef® PARA and Udel® PSU deliver metal-like tensile strength and cost-efficient sterilization performance.

• Reusable Instruments: Radel® PPSU, AvaSpire® PAEK, and KetaSpire® PEEK provide superior toughness, hydrolytic stability, and long-term sterilization durability without significant loss of mechanical properties.

   

Quality, Standards, and Regulatory Assurance

All Syensqo specialty biomaterials are tested under:

• ISO 10993 for biocompatibility
• USP Class VI for biological reactivity
• FDA Master Access Files (MAFs) available to support OEM regulatory submissions

Our materials are produced under ISO 13485-certified and GMP-compliant conditions, ensuring consistent global quality and traceability.