RegulatorySpine

Astura Medical Receives FDA 510(k) Clearance For OLYMPIC MIS Posterior Spinal Fixation System

CARLSBAD, CA – November 26, 2018 – Astura Medical, a high-growth, innovative spine technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Olympic Minimally Invasive Surgery (MIS) Posterior Spinal Fixation System.

The Olympic MIS system delivers a new level of intraoperative flexibility and efficiency by allowing surgeons to customize to their preferred workflow through the utilization 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 utilizing,” said Joel Gambrell, President and CEO of Astura. “I’m proud of the system that our team of engineers and surgeon designers developed. Olympic MIS once again accomplishes our goal of continuing to bring technology to the market that further enhances the ability of our surgeon partners to provide the best in patient care.”

The full commercial release for Olympic MIS in December represents the fourth differentiated technology delivered to the market by the company in 2018.

About Astura Medical

Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

Media Contact:

Steve Haayen

Astura Medical

858.472.8825 steve@asturamedical.com

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Mason Krell

Mason began his career in the Orthopedic Industry in 2017 when he joined The De Angelis Group as a Research Manager. He has developed a strong network within the industry and is very dedicated to helping companies maximize opportunities and disrupt markets.

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