FDA 510(k) clearance for Astura Medical’s spinal fixation system

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FDA 510(k) clearance has been granted for the Olympic minimally invasive surgery (MIS) posterior spinal fixation system (Astura Medical).

The Olympic MIS system delivers a new level of intraoperative flexibility and efficiency by allowing surgeons to customise to their preferred workflow through the utilisation of either a traditional jamshidi/guide wire technique, awl-tap wireless technique, or single-step wireless technique for the placement of MIS pedicle screws.

The system features an extensive offering of pedicle screw options, including iliac fixation, in either an extended tab (no assembly) or tower/screw (single step assembly) option. Designed to address even the most complex pathologies, Olympic MIS provides the versatility to accommodate multiple rod diameters in either titanium or cobalt chrome in pre-bent lordotic, straight, or pre-bent kyphotic options.

The instrumentation further supports a streamlined and reproducible procedural sequence by providing up to 50mm of reduction, along with multiple options for compression or distraction, including the ability to span multiple levels simultaneously.

“With the increasing rates of MIS adoption and further complexity of pathologies being treated, it was paramount that we addressed the wide range of techniques that surgeons are currently utilising,” said Joel Gambrell, President and CEO of Astura.

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