FDA Clears Spinal Resources Pedicle Screw System

With FDA 510(k) clearance of its Swedge pedicle screw system, Florida-based Spinal Resources, Inc. says the company has now transitioned from a design and distribution firm to a full manufacturer of surgical products.

For its first product development effort, the company introduced the Swedge Pedicle Screw System, which has three rod sizes in one tool.

The system offers cobalt/chromium and titanium tulips; double lead and cortical cancellous threads; polyaxial, monoaxial, reduction, and iliac screws; and MIS (minimally invasive spinal surgery) options. Currently, the Swedge system is cleared for a 5.5mm rod; 4.75mm and 5.0mm rods are pending clearance.

The company has been developing the 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.

With the system, the company said it hopes to reduce OR time, costs and inventory management. It does this by “giving clinicians more surgical flexibility in degenerative, deformity, and midline approach surgeries.”

On September 7, 2017, the company’s President and CEO Bernard Bedor said no other screw on the market is quite like the Swedge.

“We believe we’ve done something unique with our product. We’ve taken three different rod sizes, put them into one effective tulip, and can lock them with a one-step locking cap.” He says the system provides surgeons with “greater versatility in the pre-planning and inter-operative stages, effectively reducing the surgical ‘fiddle factor.’”

With the ownership of four patents (and two more under consideration), the company stated, “This FDA clearance, and several other promising products in its pipeline, SRI is standing out as a strong contender in the design and manufacture of innovative solutions that enhance surgical procedures. The company is exploring full commercialization via strategic partnership, license, and/or private/corporate funding.”

Intended Use

The company says the system is intended “to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudoarthrosis, and failed previous fusion.

“It is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally-mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: DDD (degenerative disc disease), trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.”