Precision Spine, a US-based spinal device company, has secured the US Food and Drug Administration 510(k) clearance for the additional components of its Reform pedicle screw system for treating spinal deformities.
Clearance covers components such as a rod-to-rod connector, pedicle, laminar and transverse process hooks, lateral offset connectors, as well as parallel cross links and axial domino connectors.
The Reform system equipped with these additional components will increase the efficiency of application and ease of ergonomic use in achieving alignment and correction at each level of the thoracic, lumbar and sacral spine.
Precision Spine states that Reform 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 using 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 tumours and failed previous fusion (pseudarthrosis).
The Reform system is also indicated for non-cervical pedicle screw fixation.
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Precision Spine president Rich Dickerson said: “We are very pleased to have received FDA clearance on these additional components of our Reform pedicle screw system.
“Feedback on the system has been extremely positive to date, and the addition of these new components should further strengthen the growth we are seeing in the adoption of this product by the surgeon community.”
According to GlobalData estimates, the pedicle screw systems devices in the US was valued at $1.84bn in 2012 and is expected to grow at a CAGR of 2.0% to reach $2.12bn by 2019.
Image: Reform pedicle screw system. Photo: courtesy of Business Wire.