SpineGuard has announced the filing of its 510(k) regulatory dossier with the US Food and Drug Administration (FDA), as it seeks authorisation to commercialise 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 broach and clear the regulatory pathway tied to the innovative applications that we launch.
“We are very pleased to have assembled this regulatory file which is substantial because for the first time in the history of the company it supports 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.
“The Threaded PediGuard and its DSG Connect interface presents the most elaborate device of our range today. This paired solution triggered the highest demand from our users to address the anterior application, particularly for deformity correction, as it has evolved into an increasingly growing market.
“This envisioned clearance integrates perfectly in the context of the recently announced strategic collaboration with Wishbone Medical, in order to boost our mutual sales in the adolescent surgery segment.”