MiRus today said it received FDA 510(k) clearance for its IO expandable lumbar interbody.
Marietta, Georgia-based MiRus designed the expandable lumbar interbody to be used in PLIF and TLIF procedures. It has a low insertion profile at 4 mm, an expansion of 18 mm and a 24º lordosis.
Get the full story on our sister site, Medical Design & Outsourcing.
MiRus today said it received FDA 510(k) clearance for its IO expandable lumbar interbody.
Marietta, Georgia-based MiRus designed the expandable lumbar interbody to be used in PLIF and TLIF procedures. It has a low insertion profile at 4 mm, an expansion of 18 mm and a 24º lordosis.
“The FDA approval of the IO expandable lumbar interbody is a breakthrough for surgeons and patients wishing truly less invasive spine surgery,” founder and CEO Jay Yadav said in a news release. “It also marks a significant milestone in our development of complex rhenium-based medical implants.”
The one-step expandable implant allows for 2.5cc of biologic to be post-packed in the intervertebral space. It also allows for minimization of insertion height and maximization of expansion height, lordosis to make it easier for surgeons to restore lordosis, maintain sagittal balance and reduce insertion and related neural injury challenges, according to the comp…