3-D printed spine approved by the FDA
The U.S. Food and Drug Administration (FDA) approved the first 3-D printed spinal implant this summer.
Manufactured by Oxford Performance Materials, Inc., the SpineFab vertical body replacement implant system is made using biocompatible polymer and laser light. It’ll be made in 48 sizes to replace collapsed, damaged or unstable vertebral body because of a tumor or trauma.
After extensive testing, the FDA cleared the implant, which is radiolucent and has bone-like mechanical properties and bone ongrowth characteristics, for long-term use.
“We have built a strategy with the patient in mind by working together with clinicians to bring innovative device solutions that anticipate improved surgical outcomes,” says Severine Zygmont, President of OPM Biomedical. “Today we have achieved our goal to build the first 3-D printed polymer implant that has been cleared for a load bearing indication. Our OsteoFab process, which combines 3-D print- ing 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 more information, visit oxfordpm.com.
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