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The Food and Drug Association recently cleared the SpineFab vertebral body replacement (VBR) system by Oxford Performance Materials (OPM). This is the first 3D-printed spinal implant device to be cleared for a load-bearing indication and is suitable for long-term use in patients.

This isn’t the first 3D-printed OPM device cleared by the FDA. In 2013, the FDA cleared a 3D-printed cranial prosthesis and, in 2014, a patient-specific facial implant. Both of the previously approved devices are distributed by Zimmer-Biomet.

“Receiving FDA clearance for our SpineFab system is a significant accomplishment for our team and a key milestone for OPM,” said Scott DeFelice, OPM chief executive officer and chairman. “This clearance serves as further confirmation of our ability to repeatedly build fully functional 3D-printed parts.”

The SpineFab device is intended for use in the thoracolumbar regions of the spine to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. Through the company’s OsteoFab manufacturing process, the implants will be 3D-printed in 48 different sizes using only biocompatible polymer and laser light.

In the press release, OPM announced that the device, 3D-printed using OPM’s proprietary OXPEKK powder, has undergone rigorous testing and met all weight and fatigue requirements necessary for its intended long-term use.

Severine Zygmont, president of OPM Biomedical, said “Today we have achieved our goal to build the first 3D printed polymer implant that has been cleared for a load bearing indication. Our OsteoFab process, which combines 3D printing with a unique material chemistry, is causing the industry to rethink how implants are designed and manufactured. We can now envision devices that will promote bone tissue formation while being imaging friendly and anatomically desirable.”

For Further Information
More on spinal implant devices can be found in the report published by iData entitled U.S. Market for Spinal Implants & Vertebral Compression Fractures. This report covers the U.S. and includes the following market segments: cervical fixation, thoracolumbar fixation, interbody devices, motion preservation devices, vertebral compression fractures, and spinal electrical stimulation.

The global series on the spinal implant and VCF markets covers the U.S., Australia, Japan, South Korea, China, Taiwan, and 15 countries in Europe. Full reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.

Register online or email us at [email protected] for a U.S. Market for Spinal Implants and VCF report brochure and synopsis.

About Procedure Tracker
Additional procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by country, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.

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