Astura Medical has obtained FDA 510(k) clearance for the Masada Fenestrated Screw System, expanding the capabilities of the Masada platform with a design focused on fixation reliability and procedural efficiency.
Rather than representing only a regulatory milestone, the approval introduces an additional surgical option aimed at addressing cases where bone quality compromises fixation stability.
The system incorporates PMMA bone cement augmentation to improve anchorage in challenging clinical scenarios, including poor bone density, trauma, tumors, and other complex thoracic, lumbar, and sacral pathologies.
Key System Features
- Enhanced fixation in compromised bone
Fenestrated and cannulated screw designs allow controlled PMMA delivery, supporting improved implant stability and integration in weakened vertebral structures. - Intraoperative efficiency
Dedicated instrumentation enables accurate and efficient cement insertion using surgeon-preferred techniques, applicable in both single- and multi-level procedures. - Platform integration
The system is fully compatible with Masada Open and Masada MIS systems, allowing continuity of workflow and intraoperative flexibility. - Versatile application
Designed for complex pathologies requiring augmentation, the system supports construct stability while maintaining procedural adaptability.
The development reflects collaboration across engineering, regulatory, and clinical teams, bringing an additional fixation strategy to surgeons managing compromised bone conditions.
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 Orthopedic Spine market. Website: http://www.asturamedical.com