BoxSPINE was granted FDA 510(k) clearance to market DUET Spinal Fixation, 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).
DUET was developed to address limitations of rod-and-pedicle screw systems 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.
In mechanical testing, DUET 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.
BoxSPINE was granted FDA 510(k) clearance to market DUET Spinal Fixation, 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...
BoxSPINE was granted FDA 510(k) clearance to market DUET Spinal Fixation, 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).
DUET was developed to address limitations of rod-and-pedicle screw systems 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.
In mechanical testing, DUET 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.
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