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.

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.

“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.