Medicrea has secured approval from the US Food and Drug Administration (FDA) for its K-Jaws cervical compression staple for all cervical fixation indications carried out with interbody cages.
K-Jaws is claimed to be considerably less invasive and much quicker to insert than any cervical plate currently on the market.
The K-Jaws cervical compression staple involves fixing two adjacent vertebra by compression around a previously-inserted interbody cage to ensure better stability.
Medicrea chairman and CEO Denys Sournac said: "Given this technology’s highly innovative aspect and its unique design on the market, this approval process was the longest and most complex we have every had to administer with the FDA, but we have now reached a decisive milestone.
"Following an examination of the product’s clinical data – almost 5,000 units have already been implanted outside the US since the product’s launch in 2006 -the FDA has approved our cervical staple in the US market for the same indications as cervical plates.
"This approval has given rise to the creation of a new product code in the FDA’s internal classification, giving the product a unique position on the spinal column fixation device market."
"We are therefore free to openly negotiate again, which is particularly fitting given that since then other companies had indicated their interest in distributing the product subject to the company obtaining FDA approval in the US"
Medicrea had signed an exclusive licensing pre-agreement in 2009 with an American partner to market the K-Jaws in the US and, as an option, the rest of the world.
The company said that given the significantly longer than expected time taken to obtain FDA approval for the K-Jaws, it is no longer bound by this agreement.