A Texan medical device company has received FDA approval for five new spinal implants 3D printed in titanium.
The family of five FDA 510(k)-cleared lumbar interbody fusion devices is being brought to market by Osseus Fusion Systems under the brand name, Aries. Osseus has been working to develop advanced technology products to enable minimally invasive surgery since it was founded in 2012. In doing so, the company has developed PL3XUS, its proprietary 3D printing technology which uses powder bed fusion to build parts in titanium.
Aries devices boast 80% porosity, increased bone packability and low stiffness, per Osseus, and are manufactured in 30-micron layers before being sintered. A rigorous post-processing phase then optimises the devices ready for clinical use.
The implants are designed to help surgeons ease back pain, and are said to help with faster healing, improved bone growth and enhanced radiovisibility. They represent the first FDA-cleared 3D printed implants Osseus has developed, and double the volume of the company’s portfolio. Osseus says Aries is the first range of many 3D printed products it is working on, and with more to come, the company believes it now has an edge over its competitors.
Photos: Osseus Fusion Systems / TCT Magazine