BoxSPINE LLC has announced U.S. Food and Drug Administration (FDA) clearance for the DUET Spinal Fixation System, a three-piece spinal stabilization system designed to eliminate the need for traditional rods.
For decades, spinal fixation has relied on rod-and-pedicle screw systems first introduced in the 1960s. While widely used, these systems are complex, costly, and dependent on multiple components with known mechanical failure points. They also require extensive instrument sets and inventory, increasing procedural burden for hospitals and ambulatory surgery centers (ASCs).
The DUET system was developed to address these limitations with a simplified construct. Instead of relying on rods, the system uses a three-piece design in which a halo device captures a spherical implant head, creating 360° contact and allowing 35° to 60° of articulation depending on patient anatomy. The components are secured with a locking cap that engages directly with the implant.
This design leverages triangular geometry, one of the most stable structural forms in engineering. In mechanical testing, the DUET system demonstrated greater strength than predicate devices and more than double the stiffness, improving resistance to deformation under load.
Unlike traditional systems that require hundreds of instruments and implant variations, the DUET™ platform is streamlined, with minimal SKUs and a disposable, single-use sterile instrument kit. This reduction in complexity supports efficiency in the operating room and makes the system well-suited for ASC environments.
“FDA clearance of the DUET Spinal Fixation System gives surgeons an exciting and innovative option for their patients,” said Richard G. Fessler, MD, PhD, of Rush University Medical Center. “DUET is designed without the main failure mechanisms like rods and tulip heads whose limited contact weakens traditional pedicle screw systems. Instead, it uses a triangle, the strongest geometry in architecture and engineering.”
“Beyond eliminating the rod, we’ve eliminated 90% of the instruments and inventory required for one-level lumbar fusion,” said Richard Cranford, CEO of BoxSPINE. “This creates a cost-conscious solution for ASC settings.”
The global spinal implant market exceeds $10 billion annually, with millions of patients seeking treatment for spinal disorders each year. Yet the foundational technology behind many procedures has remained largely unchanged for decades, contributing to rising costs across the healthcare system. The DUET system represents a shift toward simpler, more efficient spinal stabilization designed to meet the demands of modern surgical practice.
BoxSPINE will be at ISASS. Visit them at Booth 314.
