SpineGuard has received 510(k) clearance by the US Food and Drug Administration for the commercial release in the USA of its Threaded PediGuard device for anterior approach instrumented spine surgery.
Stéphane Bette, co-founder and deputy CEO of SpineGuard, said: “SpineGuard’s revenues are largely generated by the US market which is also the first market worldwide in our sector that strongly rewards innovation. Therefore, our priority is to quickly clear the innovative applications that we launch.
“We are very pleased to have obtained this important regulatory clearance in record time since we just filed in January this year. It is the very first file in the company’s history to demonstrate the efficacy of our PediGuard device in a new spinal application different from pedicle screw trajectory preparation: accurately facilitating the insertion of screws in vertebral bodies from an anterior approach.
“We will now be able to fulfil the strong demand from our users to use the Threaded PediGuard and its DSG Connect interface in anterior approach, particularly for deformity correction, as it has evolved into an increasingly growing market.
“This clearance integrates perfectly in the context of the already promising strategic collaboration with Wishbone Medical, in order to boost our mutual sales in the adolescent surgery segment.”