510(k) clearance for DIPLOMAT®
SIGNUS Medizintechnik receives 510(k) clearance for posterior pedicle screw system DIPLOMAT®
Alzenau, October 24, 2016. In august SIGNUS announced the 510(k) clearance from the United States Food and Drug Administration (FDA) for their new DIPLOMAT pedicle screw system.
The DIPLOMAT has been developed in cooperation with international spine experts. As a posterior fixation system it provides user-friendly and reliable instrumentation for all spine treatments.
“The main focus of DIPLOMAT is the optimized balance between clinical perfor- mance and user-friendliness,” says SIGNUS Managing Director, Uwe Siedler. The system combines maximal clinical efficiency with all the important properties required for optimal patient treatment.
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 only 14.9 millimeters guarantees optimal anatomical alignment and prevents any protrusion of the tulip even in slim or young patients. The patented ELASTOLOK® locking mechanism ensures the highest strength for the screw/tulip connection. The DIPLOMAT system provides optimal flexibility and efficiency thanks to these features.
DIPLOMAT impresses users not only with its high level of safety but also with its ease of handling during surgery. All the pedicle screws are cannulated, as well as being fenestrated from a diameter of 5.5 millimeters. The comfortable screw-cannula diameter of 1.9 millimeters also allows the use of stronger guide wires, which noticeably stabilizes the insertion of the pedicle screw during MIS procedures. The DIPLOMAT pedicle screws have a self-tapping double thread that provides the best possible fixation and perfect anchoring in the bone. The high thread pitch enables faster insertion which considerably shortens surgery time.
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