Medicrea has announced that the FDA has approved its K-Jaws cervical compression staple for all cervical fixation indications carried out with interbody cages. The company states that the device consists of fixing two adjacent vertebras by compression around a previously-inserted interbody cage and results in good stability thanks to the axial localisation of the compression force at the level of the spine’s vertebral bodies.
“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 ever had to administer with the FDA, but we have now reached a decisive milestone,” says Denys Sournac, chairman and chief executive officer of Medicrea.
He adds: “Following an examination of the product’s clinical data—almost 5,000 units have already been implanted outside the USA 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.”