FDA Clears New Components for Precision Spine's Reform Pedicle Screw System
Precision Spine Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the following additional components of its Reform Pedicle Screw System for the treatment of spinal deformities: a rod to rod connector; pedicle, laminar and transverse process hooks; lateral offset connectors; and parallel cross links and axial domino connectors.
According to company officials, the new components expand and enhance the Reform system by providing the ability to achieve alignment and correction at each level of the thoracic, lumbar and sacral spine.
“Our product development efforts continue to fuel strong growth for us,” Rich Dickerson, president of Precision Spine 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.”
The Reform system offers new polyaxial and uniplanar pedicle screw designs, both of which incorporate a triple lead thread and cobalt chrome tulip head. Titanium and cobalt chrome rods are included as well as titanium cross connectors. The ergonomic instrument set included a “strong yet versatile” reduction and direct vertebral de-rotation tower system, the company says.
The Reform Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
The Reform Pedicle Screw System also is intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebrae) 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: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); spinal tumor; pseudarthrosis; and failed previous fusion.
“With the addition of the hooks and various connectors, I feel that there is a multitude of possibilities for the use of the Reform Pedicle Screw System,” said Krishn M. Sharma, M.D., Westchester Medical Center, Valhalla, N.Y. “From degenerative conditions, to scoliosis, to complex revision surgeries, the Reform system is equipped with the necessary components to enable me to address any case."
Precision Spine is a privately held company headquartered in Parsippany, N.J. with manufacturing facilities in Pearl, Miss.