Amedica Corp. won FDA 510(k) clearance for a 2nd generation of the company’s cervical and lumbar interbody fusion devices (IBF).
The Utah- based spinal and reconstructive medical device manufacturer said the devices, which are made with a proprietary silicon nitride biomaterial, could help surgeons perform minimally invasive procedures when conducting lumbar lateral interbody fusion (LLIF).
Minimally invasive LLIF procedures help reduce operative time, postoperative pain and length of hospital stay, according to the company.
"Amedica is now better positioned to deliver a technology that can change the standard of care for spinal surgery," president & CEO Eric Olson said in a prepared release. "The enhancements we have made to our interbody line of products including the LLIF devices speak to our long term commitment to improve interbody fusion procedures by providing a premium product that enhances the surgeon experience while dramatically improving patient outcomes."
Amedica said the company could play in the $1.5 billion IBF market and the $147 million LLIF market, the company said. The 1st products are expected to launch in the 4th quarter of this year.