Oxford Performance Materials achieved FDA 510(k) clearance for the SpineFab VBR implant system.
Here are five things to know:
1. The SpineFab system is the first FDA-cleared three-dimensional printed load bearing polymer device for long-term implantation.
2. This is OPM's third OsteoFab FDA clearance. The first was achieved in February 2013 with the OsteoFab Patient-Specific Cranial Device. Last year the company achieved clearance for the OsteoFab Patient-Specific Facial Device.
3. The SpineFab is a vertebral body replacement for use in the thoracolumbar region of the spine to replace collapsed, damaged or unstable vertebral body due to tumor or trauma.
4. The system underwent extensive static and dynamic medical testing to meet load and fatigue requirements to achieve clearance. The system also meets regulatory guidelines for intended use.
5. The SpineFab implants will be 3D printed in 48 sizes by OPM Biomedical, the original equipment manufacturer. The OsteoFab laser sintering additive manufacturing process is a clean implant production method, and all SpineFab implants will be manufactured using OPM's OsteoFab process.
6. OPM is in discussion with distributors about sales channels for the SpineFab VBR system as well as partnership options for orthopedic devices in development. OPM's OsteoFab Patient-Specific Cranial and Facial devices are exclusively distributed by Zimmer Biomet.