Spinal Resources Inc. announced on Thursday that its Swedge Pedicle Screw System scored FDA clearance.

The system immobilizes and stabilizes spinal segments during the treatment of acute and chronic spine instabilities and deformities. That includes degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, pseudarthrosis and failed previous fusion.

The global spinal fusion market was valued at $7.1 billion in 2016 and is expected to reach approximately $9 billion by 2023, according to a GlobalData Healthcare report. The growth is largely due to a rise in degenerative spinal conditions in the elderly population and the introduction of technological advancements for spinal surgery.
The Swedge system allows for more versatility in the preplanning and inter-operative stages. It’s currently cleared for use with a 5.5 millimeter rod and the 4.75 millimeter and 5 millimeter rods are pending clearance.

"We believe we've done something unique with our product," Bernard Bedor, president and CEO of Spinal Resources, said in a statement. "We've taken three different rod sizes, put them into one effective tulip, and can lock them with a one-step locking cap.”

It’s equipped with CoCr and Titanium tulips, double lead and Cortical Cancellous Threads, and Polyaxial, Monoaxial, Reduction and Iliac screws. The system is able to hold the tulip’s position while contouring rods in a multilevel scenario, and the transition rod gradually tapers between sections to reduce stress risers.

Swedge is also capable of performing minimally-invasive surgery, which means less tissue disturbance, a reduction in recovery time and better clinical outcomes.

Spinal Resources has four patents and two additional ones under consideration, as well as several other promising products in the works. The company is exploring full commercialization through strategic partnerships, a license and/or private/corporate funding.

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