New Spinal Fixation System Eliminates Rods to Streamline Surgery

As a result, clinicians are seeking stabilization options that simplify workflows while maintaining biomechanical strength. A new system has launched that eliminates rods with a three-piece design and now has U.S. Food and Drug Administration (FDA) clearance.

BoxSPINE, LLC has received U.S. FDA clearance for the DUET Spinal Fixation System, a posterior, minimally invasive stabilization platform designed to improve patient experience while enhancing fusion strength. The construct removes the need for traditional rods and is intended to streamline procedures in ambulatory surgery center (ASC) environments. It addresses long-standing procedural complexity by minimizing components and inventory requirements.

Instead of a rod-and-tulip assembly, the DUET system uses a halo device that captures a spherical implant head to create 360-degree contact. The construct allows 35 to 60 degrees of articulation depending on patient anatomy, and the components are secured with a locking cap that engages directly with the implant. The design leverages triangular geometry to promote stability within the fixation construct.

In mechanical testing, the system demonstrated greater strength than predicate devices and more than double the stiffness, improving resistance to deformation under load. The platform also reduces setup demands compared with traditional systems that can require hundreds of instruments and numerous implant variations. DUET is delivered with minimal stock-keeping units (SKUs) and a disposable, single-use sterile instrument kit to support operating room efficiency and ASC adoption.

With millions of patients treated for spinal disorders each year and a global spinal implant market exceeding USD 10 billion, the DUET system is positioned as a simpler, more efficient stabilization option aligned with modern surgical practice.

“FDA clearance of the DUET™ Spinal Fixation System gives surgeons an exciting and innovative option for their patients. 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.” said Richard G. Fessler, MD, PhD, neurosurgeon and professor, Rush University Medical Center

“Beyond eliminating the rod, we’ve eliminated 90% of the instruments and inventory required for one-level lumbar fusion. This creates a cost-conscious solution for ASC settings.” said Richard Cranford, CEO, BoxSPINE

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