Spinal Resources receives FDA 510(k) clearance for new pedicle screw system

The Swedge Pedicle Screw System received FDA 510(k) clearance to be used with a 5.5-mm rod, according to an announcement from Spinal Resources Inc., which manufactures the system.

The Swedge system includes cobalt-chromium and titanium tulips; double-lead and cortical cancellous threads; polyaxial, monoaxial, reduction and iliac screws; and options that allow for minimally invasive spine surgery, according to a press release. FDA clearance to use 4.75-mm and 5-mm rods with the Swedge Pedicle Screw System is pending, according to the release.

This technology, which is the company’s first product, accommodates multiple rods in a single-screw tulip with single-locking cap, which effectively locks the tulip’s angle without the presence of a rod. The system then maintains the tulip’s position while rods are contoured during multi-level surgical scenarios.

“We believe we’ve done something unique with our product,” Bernard Bedor, president and chief executive officer of Spinal Resources, said in the release. “We’ve taken three different rod sizes, put them into one effective tulip, and can lock them with a one-step locking cap. The Swedge System provides surgeons with greater versatility in the pre-planning and interoperative stages, effectively reducing the surgical ‘fiddle factor’ thanks to its convenient standard and transition rods and screws in a variety of diameters and lengths.”

Reference:

spinalresourcesinc.com