Precision Spine has obtained the US Food and Drug Administration's (FDA) 510(k) clearance for its new deformity correction system, designed for treating acute and chronic instabilities of thoracic, lumbar and sacral spine.
The ReForm Pedicle Screw system features polyaxial and uniplanar pedicle screws incorporating triple lead thread and cobalt chrome tulip head as well as titanium, cobalt chrome rods and titanium cross connectors.
The system immobilizes and stabilizes spinal segments in skeletally mature patients with degenerative spondylolisthesis and having evidence of neurological impairment, 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 new deformity correction system will increase its efficiency of application and ease of ergonomic use as well as promote patient safety.
"I believe it will be recognized as one of the most useful deformity correction systems available to the spine surgeon community when it launches later this year," Taddonio added.