HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, Inc., a medical device company that designs, develops, manufactures, and markets products for the surgical treatment of spinal disorders, announced today their 510k for ARx SAI (Sacral Alar Iliac) Spinal Fixation System was approved. ARx SAI has expanded its compatibility clearance and is now approved for use with compatible pedicle screws with 5.5mm or 6.0mm 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. The screw shank is derived from the proven 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,” said Rich Mueller, CEO of Life Spine, Inc. “With ARx SAI approved for use with 5.5mm and 6.0mm 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:
- Self-drilling screws eliminate surgical steps to increase efficiency and save time
- Self-harvesting design packs bone into fenestrations upon insertion
- Low-profile Cobalt Chrome tulip head for greater strength
- Universal T25 hexalobe drive features for ease of use and simplicity
- Compatible with 5.5mm or 6.0mm Titanium and Cobalt Chrome Rods*
*Refer to the Additional Compatibility Information section in the IFU for specific rod conditions.
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.
Contacts
Mr. Joe Fricano
Chief Financial Officer
jfricano@lifespine.com
847-884-6117