US FDA clears Spinal Resources’s Swedge pedicle screw system

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Spinal Resources has received US Food and Drug Administration (FDA) 510(k) clearance for its Swedge pedicle screw system. This system offers multiple features including titanium tulips, double lead and cortical cancellous threads; polyaxial, monoaxial, reduction, and iliac screws; and minimally invasive spinal surgery options.

Currently, the Swedge system is cleared for a 5.5mm rod, while 4.75mm and 5mm rods are pending clearance.

Spinal Resources has been developing its technology since 2005, which accommodates multiple rods in a single-screw tulip with single-locking cap, and effectively locks the tulip’s angle without the presence of a rod.

SRI’s system holds the tulip’s position while contouring rods in a multi-level scenario. The transition rod features a gradual taper between sections to minimise stress risers. Designed to improve efficiencies within the current and trending hospital environment by reducing inventory and increasing surgical procedure options, Spinal Resources, all-in-one Swedge implant system is intended to give clinicians more surgical flexibility in degenerative, deformity, and midline approach surgeries, with a wider range of options to stabilise and conform to varying anatomies.

“We believe we have done something unique with our product,” president and chief executive officer Bernard Bedor says. “We have 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 versatility in the pre-planning and inter-operative stages, effectively reducing the surgical ‘fiddle factor’ thanks to its convenient standard and transition rods and screws in a variety of diameters and lengths.”

Swedge is the company’s first product development effort. According to a company release, the FDA clearance marks the transition of Spinal Resources from design and distribution experts into full manufacturers of innovative surgical enhancements. In addition, the company holds four patents, with two more under consideration.

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