Signus receives US FDA 510(k) clearance for Diplomat posterior pedicle screw system



Signus has received 510(k) clearance from the US Food and Drug Administration (FDA) for the new Diplomat pedicle screw system.

The Diplomat has been developed in cooperation with international spine experts. As a posterior fixation system, it is intended to provide user-friendly and reliable instrumentation for all spinal treatments.

According to a press release, the pedicle screws are a modular two-piece implant: depending on the indication and surgical application, the pedicle screws can be assembled as required with the appropriate tulips. If necessary, the tulips can be removed and replaced in situ during surgery. A very low tulip profile of 14.9mm is designed to guarantee optimal anatomical alignment and prevent any protrusion of the tulip, even in slim or young patients. The patented Elastolok locking mechanism is intended to ensure a high-strength screw/tulip connection.

All the pedicle screws are cannulated, as well as being fenestrated from a diameter of 5.5mm. The comfortable screw-cannula diameter of 1.9mm also allows the use of stronger guide wires, which, according to a press release, stabilises the insertion of the pedicle screw during minimally invasive procedures. The screws have a self-tapping double thread intended to offer good fixation and anchoring in the bone. The high thread pitch is designed to enable faster insertion.