safety profile

Safe and Biostable PEEK Polymer Solutions

All Invibio® products are high-performance polymeric biomaterials, engineered for biocompatibility, safety, and biostability — and featuring a proven history of clinical results and regulatory approval.

As the long-term health concerns about the effects of metal ions resulting from long-term implantation of metallic devices continue to be explored, our non-metallic biomaterials provide not only peace of mind but also imaging benefits that allow clear assessment of the healing site by all conventional technologies.

Extensive testing of implantable PEEK-OPTIMA®, MOTIS®, and ENDOLIGN® biomaterials to ISO 10993 standards demonstrated no evidence of cytotoxicity, systemic toxicity or irritation. These results have been lodged with the US FDA.

PEEK-CLASSIX® is tested to the standards required for US Pharmacopeia Class VI Certification, which allows short-term tissue contact.

For more safety profile information on our PEEK polymer products, contact Invibio today.