FDA OKs BoxSPINE’s Rodless Spinal Fixation System

BoxSPINE has obtained U.S. Food and Drug Administration (FDA) clearance for the DUET spinal fixation system, a three-piece spinal stabilization system designed to remove the need for traditional rods.

Spinal fixation has relied on rod-and-pedicle screw systems since they were first introduced in the 1960s. They’re widely used, but the systems are complex, costly, and depend on multiple components with known mechanical failure points.

They also need extensive instrument sets and inventory, which can increase procedural burden for hospitals and ambulatory surgical centers (ASCs).

Instead of relying on rods, the DUET 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, which engages directly with the implant.

Its design utilizes triangular geometry, one of the most stable structural forms in engineering. In mechanical testing, the system showed more strength than predicate device and over double the stiffness, boosting resistance to deformation under load.

The DUET platform is streamlined, BoxSPINE said, with minimal SKUs and a disposable, single-use sterile instrument kit. This supports efficiency in the OR 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, Ph.D., 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,” added Richard Cranford, CEO of BoxSPINE. “This creates a cost-conscious solution for ASC settings.”