FDA Clears Spinal Resources’ Swedge Pedicle Screw System

Spinal Resources Inc. (SRI) announced that it has received FDA 510(k) clearance for its Swedge Pedicle Screw System. This unique system offers multiple benefits, including CoCr 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.
 
Since 2005, Spinal Resources Inc. has been developing its groundbreaking technology, 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. The FDA’s clearance of the Swedge Stabilization System marks the transition of Spinal Resources Inc. from design and distribution experts into full manufacturers of innovative surgical enhancements. The Swedge system is the company’s first product development effort–and a seminal achievement: 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 minimize stress risers. Designed to improve efficiencies within the current and trending hospital environment by reducing inventory and increasing surgical procedure options, which may result in more affordable alternatives for patients, Spinal Resources Inc.’s versatile, all-in-one Swedge implant system gives clinicians more surgical flexibility in degenerative, deformity, and midline approach surgeries, with a wider range of options to stabilize and conform to varying anatomies. Its MIS capabilities offer patients a smaller incision, with the added benefits of less tissue disturbance, reduced rehab/recovery time, and enhanced outcomes.
 
A report from GlobalData Healthcare, a UK-based company specializing in providing business data and analytics, indicated the 2017 global spinal fusion market is experiencing steady growth of about 3.4 percent CAGR (compound annual growth rate). The market is estimated to rise from $7.1 billion in 2016 to approximately $9 billion by 2023. The December 2016 report attributes the increase to degenerative spinal conditions caused by aging and the prevalence of technological advancements in surgeries.
 
According to president and CEO Bernard Bedor, no other screw on the market is quite like the Swedge System in capability. “We believe we’ve done something unique with our product,” he said. “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 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. Our focus at SRI is to be problem-solvers for patients by supporting surgeons and hospitals in their important work with fewer instruments and a smarter system that shorten operating room time and lower costs.”
 
With the ownership of four patents (and two more under consideration), 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 Swedge Pedicle Screw Fixation 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.