US FDA clears DeGen Medical’s F1 MPS modular pedicle screw system

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DeGen Medical F1 MPS
DeGen Medical F1 MPS

DeGen Medical has received clearance from the US Food and Drug Administration (FDA) for its F1 modular pedicle screw system for the company’s Joust minimally invasive surgery procedure. The Joust minimally invasive technology is a modular pedicle screw with cobalt-chrome alloy head for percutaneous procedures.

According to a company release, the Joust technology includes minimally invasive Towers for percutaneous screw placement, traditional or cortical approach, and rod reduction is built in the Tower. The rod insertion tool with Joust’s minimally invasive rods is designed to aid in achieving a stable fusion construct without undergoing the traditional open approach.

The procedure is intended to allow the surgeon to place the pedicle screws with minimal muscle stripping causing reduced muscle damage and lessening scar tissue formation from decreased dissection. The instrumentation is designed to allow for smooth implantation in a complex lumbar spinal surgery over multiple levels.

The Joust minimally invasive technology with the F1 MPS system is due for release in the fourth quarter of 2016.

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