DEXA SOLO-L is a 3D printed, standalone anterior lumbar interbody fusion and lateral lumbar interbody fusion (ALIF & LLIF) device, developed based on Aurora’s patented DEXA technology platform
DEXA SOLO-L is part of the DEXA Technology Platform. (Credit: GlobeNewswire/Aurora Spine Corporation)
Spinal surgery devices company Aurora Spine has received the US Food and Drug Administration (FDA) 510(k) approval for its DEXA SOLO-L spinal fusion system.
DEXA SOLO-L is a 3D printed, standalone anterior lumbar interbody fusion and lateral lumbar interbody fusion (ALIF & LLIF) device.
The company developed the device based on its patented DEXA technology platform.
It is the world’s first patented and FDA-cleared, colour-coded ALIF standalone bone density matched implant, and a unique device for the lumbar spine, said Aurora Spine.
Aurora Spine president and chief executive officer Trent Northcutt said: “This clearance is an important step to gain new surgeon customers and new sales distribution opportunities nationwide to drive more revenue.”
Also, it is the first colour-coded, bone-mimicking structure implant available in the market, which enables doctors to match the implant to their patient’s bone quality and density.
A recently published peer-reviewed research article, which reviewed the history of spinal implants, shows the need for bone quality and density in spinal implants.
The study authors concluded that patients’ bone quality has not been previously used to guide manufacturing.
Aurora claimed that its DEXA implants are the first in the world to match a patient’s bone density and quality to a personalised implant.
The commercial launch of DEXA-L product line follows the recently released DEXA-C cervical implant product line.
Aurora Spine chief technology officer Laszlo Garamszegi said: “The DEXA SOLO-L approval demonstrates our unwavering commitment to game-changing innovation around our entire bone mimicking DEXA Technology Platform.
“We will continue developing proprietary products to strengthen our product offerings, and build off our patent portfolio, especially our patented DEXA Technology Platform.”
Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of advanced, minimally invasive, regenerative spinal implant technologies.