Astura Medical Announces FDA 510(k) Clearance For  The Masada Modular Spinal Fixation System

Astura Medical Announces FDA 510(k) Clearance For The Masada Modular Spinal Fixation System

Authored: November 23, 2023

Astura Medical, a dynamic spine technology company, is excited to announce that it has received FDA 510(k) clearance for its groundbreaking Masada Modular Spinal Fixation System.

The Masada System is a versatile spinal fixation solution designed to empower surgeons and improve patient outcomes for complex spinal pathologies. It features a wide array of modular screw options with configurable tulips, offering translation, articulation, and rotation variability for enhanced surgical efficiency. Surgeons can easily adapt to individual patient anatomies using standard, extended-top, dual-head, and high-top tulip options during surgery.

The tulips are available in polyaxial, monoaxial, or fixed-angled configurations and can be connected to 5.5 or 6.0mm rods. Cortical Cancellous screws with varying thread pitch options are provided, and the system includes self-drilling guide wireless navigated, cannulated, and stylet tip configurations. These screws come in diameters ranging from 4.0 to 10.5mm and lengths from 20 to 120mm, offering precise options for different surgical needs.

Joel Gambrell, Co-founder, and CEO, commented, “The Masada system marks a significant milestone for Astura. It empowers surgeons with unprecedented precision and adaptability, ensuring the highest standard of patient care. With this innovative system, we’re setting a new standard for excellence with best-in-class implants and instruments.”

The Masada System is equipped with a Tulip Unlocker for intraoperative tulip screw unlocking. This function simplifies the final tulip removal process with low-profile standard and high-top tulip removers, enhancing surgical efficiency. The system also includes a comprehensive range of cannulated and non-cannulated screw shank drivers, available in standard, navigated, or stickfit options, providing the precision and versatility needed for complex spinal surgeries.

Astura Medical is set to introduce several new expandable technologies in the coming months, with the Masada System marking the third clearance in 2023.