The US Food and Drug Administration (FDA) has granted 510(k) clearance to Precision Spine’s correction system to treat acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The ReForm Pedicle Screw system, which the company claims is a versatile reduction and de-rotation tower system, features polyaxial and uniplanar pedicle screws incorporating a triple lead thread and cobalt chrome tulip head, as well as titanium, cobalt chrome rods and titanium cross connectors.
By utilising new pedicle screw, rod and instrumentation technology, the system immobilises and stabilises spinal segments in skeletally mature patients with degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
Stamford Hospital orthopedic surgery director and New York Medical College scoliosis and spinal surgery professor Dr Rudolph Taddonio said the system’s design will increase its efficiency of application and ease of ergonomic use, as well as promote patient safety.
"I believe it will be recognised as one of the most useful deformity correction systems available to the spine surgeon community when it launches," Taddonio said.
Precision Spine president Rich Dickerson said; "Our ongoing focus on research and product development continues to result in new product offerings such as ReForm, which we believe will present a compelling option to surgeons seeking versatile technologies to treat spinal pathologies."
Image: The new deformity correction system immobilises and stabilises segments of the sacral, thoracic and lumbar spine. Photo: Courtesy of Business Wire.