Life Spine Announces FDA 510(k) Clearance for the ARx® SAI Spinal Fixation System

July 31, 2024

HUNTLEY, Ill., July 31, 2024–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that it has received clearance from the U.S. Food & Drug Administration (FDA) to market the ARx SAI (Sacral Alar Iliac) Spinal Fixation System.

The ARx SAI Spinal Fixation System represents the next generation in posterior fixation technology. This system can be utilized through a Sacral Alar Iliac trajectory in S1 and/or S2, providing maximum fixation across the Sacroiliac Joint. The system features versatile implants paired with streamlined ergonomic instrumentation, allowing for the construction of customized solutions tailored to each patient’s specific pathology while maintaining ease of use. The screw shank is based on Life Spine’s highly successful SImpact^® SI self-harvesting screw design, which is self-drilling and recruits autograft during insertion.

“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 customizable solutions tailored to each patient, ensuring ease of use and versatile trajectory options,” said Mariusz Knap, Senior Vice President of Sales and Marketing.

Key Features and Benefits of the ARx SAI Spinal Fixation System:

Self-drilling screws: Eliminate surgical steps, increasing efficiency and saving time
Self-harvesting design: Packs bone into fenestrations during insertion
Low-profile Cobalt Chrome tulip head: Provides greater strength and supports patients of all sizes
Universal T25 hexalobe drive: Ensures ease of use and simplicity

About Life Spine, Inc.

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.