Cortex District Member Allumin8 Receives FDA Clearance for Innovative Medical Hardware

The ortho tech startup -- led by Alyssa Huffman -- is a 2024 Arch Grants winner and an alumni of Venture Ready Missouri, a statewide collaboration between Cortex and Capital Innovators, funded by Missouri Technology Corporation.

The St. Louis-based startup Allumin8 has managed to achieve something no other medical device company ever has: clearance from the U.S. Food and Drug Administration for a type of spinal screw that’s produced through additive manufacturing. 

Allumin8 CEO Alyssa Huffman explains it’s fundamentally different from subtractive manufacturing, where a piece of metal would be whittled down into the shape of a screw. By contrast, Huffman says Allumin8’s produces its A8 INTEGR8 Porous Pedicle Screw System with a proprietary 3D printing process.

“Just because it looks the same doesn’t mean it functions the same, and that’s why the FDA puts such tight guidelines on and really hones in on understanding the additive manufactured products,” she says. “Companies have been working to try and produce this in a 5.5-millimeter diameter screw for literal decades.”