Life Spine Announces Expanded Indications for ARx SAI Spinal Fixation System

The U.S. Food and Drug Administration has granted 510(k) clearance to expanded indications for Life Spine Inc.’s ARx SAI (Sacral Alar Iliac) Spinal Fixation System. ARx SAI is now approved for use with compatible pedicle screws with 5.5mm or 6mm posterior rods made from either titanium alloys or cobalt chrome, including those from competitor systems.*

The ARx SAI Spinal Fixation System represents the next evolution in posterior fixation technology. Designed to provide robust stabilization across the sacroiliac joint, the ARx SAI system can be utilized through a Sacral Alar Iliac trajectory within the S1 or S2 pedicles. The system features versatile implants combined with streamlined instrumentation, enabling the creation of customized constructs tailored to individual patient pathology while maintaining procedural efficiency, according to the company. The screw shank is derived from the Life Spine SImpact SI self-drilling screw geometry and incorporates a self-harvesting design that facilitates autograft recruitment.

“This clearance marks an important step forward in expanding surgical flexibility and access,” Life Spine CEO Rich Mueller stated. “With ARx SAI approved for use with 5.5mm and 6mm posterior rods across titanium alloy and cobalt chrome systems, which now includes compatibility with competitive platforms, Life Spine can provide surgeons greater freedom to integrate our technology into their preferred posterior spinal constructs while maintaining the performance and reliability they expect.”

ARx SAI Spinal Fixation System features and benefits include:

• Self-drilling screws, which eliminate surgical steps to increase efficiency and save time
• A self-harvesting design to pack bone into fenestrations upon insertion
• A low-profile Cobalt Chrome tulip head for greater strength
• Universal T25 hexalobe drive features for ease of use and simplicity
• Compatibility with 5.5mm or 6mm Titanium and Cobalt Chrome Rods*

Life Spine aims to improve spinal implant treatments by increasing procedural efficiency and efficacy through innovative design, quality standards, and technologically advanced manufacturing platforms. The privately held company is based in Huntley, Ill.

* Refer to the Additional Compatibility Information section in the IFU for specific rod conditions.