Mountain View, Calif.-based medical device maker SpinalMotion will get its date with the FDA this summer, when a panel of experts will consider and make recommendations on the company’s Kineflex/C artificial disc.
On July 24, 2013, the FDA’s orthopedic & rehabilitation devices panel will review information on the Kineflex/C and made a recommendation on whether the federal watchdog agency should approve the device for the U.S. market.
"The Kineflex Lumbar Artificial Disc is a metal-on-metal (cobalt chrome molybdenum alloy) lumbar total disc replacement device," according to the FDA notice. "The Kineflex Lumbar Artificial Disc is indicated for reconstruction of the intervertebral disc at one level (L4-L5 or L5-S1) following single-level discectomy for lumbar degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies."
The agency plans to make more information available prior to the meeting.
SpinalMotion in 2010 submitted its premarket approval application for the Kineflex/C disc, which is already cleared for use in the European Union. In March 2012 the device maker won expanded CE Mark approval for 2 new, smaller sizes of the Kineflex/C Cervical devices, allowing surgeons to offer the devices to patients with smaller heights.
Earlier this year SpinalMotion closed the final tranche of a $15 million funding round that began in June 2011, according to filings. The company raised a total of $15.1 million in the offering of debt, options and warrants from 15 unnamed investors, according to regulatory documents.
