According to Invibio's website, PEEK-OPTIMA polymers feature a long history of implantation (since 1999) and successful use in regulatory approved devices.
The website goes on to say the following.
They are an industry standard in spinal fusion, and rapidly growing in other applications. PEEK-OPTIMA offers exceptional product purity, quality testing and control. What’s more, Invibio provides a "no change" supply assurance agreement, guaranteeing its long term specification and production methods.
Their proven biocompatibility and biostability is supported by US FDA Drug & Device Master files and use in thousands of regulatory approved implantable devices. In fact, no other implantable PEEK is as extensively used in US FDA, CE-marked and other regulatory body approved devices.
PEEK-OPTIMA polymer and compounds come in a range of grades and forms that offer nearly unlimited medical design and manufacturing flexibility across highly diverse applications requiring implantation or blood, bone and tissue contact greater than 30 days:
- Spinal fusion, dynamic stabilization and motion preservation
- Suture anchors
- Fixation and trauma screws
- Femoral implants
- Dental implants
- Total and partial joint replacement
- Cranio maxillofacial patient-specific implants