Life Spine has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ARx SAI Spinal Fixation System.
Representing next-generation posterior fixation technology, the system is designed for use through a Sacral Alar Iliac trajectory in S1 and/or S2, offering robust fixation across the Sacroiliac Joint.
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It includes versatile implants and ergonomic instrumentation, allowing the creation of patient-specific surgical solutions.
The screw shank is based on the company’s self-drilling SImpact SI self-harvesting screw design that facilitates autograft recruitment during insertion.
The system’s key features include self-drilling screws that streamline the surgical process by reducing steps. In addition, its self-harvesting design packs bone into fenestrations as the screw is inserted.
Life Spine sales and marketing senior vice-president Mariusz Knap said: “ARx SAI advances our commitment to innovation, positioning us among the pioneering spine companies to offer an SAI screw within our Lumbar Spinal Fixation Systems portfolio.
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By GlobalData“ARx SAI delivers customisable solutions tailored to each patient, ensuring ease of use and versatile trajectory options.”
In 2022, Life Spine obtained 510(k) clearance for its GHOST 3D-printed titanium spacer system.
The spacer system features endplate surfaces with a porous structure to promote bone growth while maintaining an external lattice geometry.
Life Spine improves the quality of life for patients with spinal issues by increasing procedural efficiency through a new design and advanced manufacturing platforms.
