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Astura Medical Receives FDA 510(k) Clearance for the Masada S2AI System

November 3, 2025 By SPINEMarketGroup

Astura Medical is proud to announce FDA 510(k) clearance of the Masada Sacral-Alar-Iliac (S2AI) System, the latest addition to our Masada Modular Posterior Fixation platform.
Designed to provide sacroiliac joint fixation and fusion, the Masada S2AI System integrates seamlessly with the full Masada implant and instrumentation platform — offering surgeons the flexibility to extend fixation from the lumbar spine to the pelvis with a single, streamlined solution.

Key Features & Benefits:
• Enhanced Fusion Potential – Cannulated and fenestrated screw shanks with self-harvesting features promote enhanced bone integration and fusion.
• Comprehensive Compatibility – Interoperable with the Masada Modular System for connection to thoracolumbar constructs using 5.5 mm or 6.0 mm titanium or CoCr rods.
• Efficiency & Versatility – Optimized for screw insertion across diverse anatomies and conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
• Proven Modularity – Modular tulip options and extended angulation provide intraoperative flexibility and versatility for complex cases.

The Masada S2AI System represents the next step in Astura’s mission to deliver innovative, surgeon-driven technologies that improve procedural efficiency and surgical outcomes.

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.To learn more, please visit: www.asturamedical.com

Filed Under: FDA APPROVED, NEWS Tagged With: 2025

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