3D Printed Spinal Implant Gains FDA Approval

Additive manufacturing (AM) has proven to be the key technology to solve a number of difficult problems. Whenever traditional manufacturing processes prove too expensive or don’t provide enough flexibility in design, AM is ready and capable to step up. The medical field in particular is one area where the flexibility of 3D printing is proving highly valuable.

Oxford Performance Materials (OPM) is one of the leaders (maybe the leader) in the new field of 3D printed implants. The company, which previously received FDA approval for its cranial and facial implants, has recently received approval for its SpineFab VBR System implants.

"Receiving FDA clearance for our SpineFab system is a significant accomplishment for our team and a key milestone for OPM,” said Scott DeFelice, CEO and chairman of OPM. “This clearance serves as further confirmation of our ability to repeatedly build fully functional 3D-printed parts and mission critical robust structures. The introduction of our SpineFab system represents exciting news for the company's entry into the attractive spinal market, and this lays the foundation for future generations of load-bearing OsteoFab implants in the orthopedic industry.”

According to the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR), there are approximately 12,500 new cases of spinal injury each year in the United States. Car crashes are the leading culprit, followed by falls. NIDILRR estimates there are currently around 276,000 individuals suffering from spinal cord injuries.

From the press release:

OPM's SpineFab device is a vertebral body replacement (VBR) intended for use in the thoracolumbar regions of the spine to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To gain this FDA clearance, OPM’s VBR implant system underwent extensive static and dynamic mechanical testing to assure it meets load and fatigue requirements as well as regulatory guidelines for its intended use.

SpineFab will be printed in 48 different sizes by OPM Biomedical, using OXPEKK polymer. OXPEKK was specifically designed by OPM for use in implants. The material is stronger than standard PEKK with a denseness and stiffness similar to bone, according to the company.

Below you’ll find a video about OPM.

Sources: OPM, NIDILRR