Precision Spine announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Reli SP spinous plating system and received expanded indications for its Reform pedicle screw system.
The Reli SP system provides surgeons with a variety of important features and benefits, including the ability to accommodate several techniques for spinous process distraction and insertion of the plate,ˮ said lead development surgeon for the system, Farzad Massoudi, president of Orange County Neurosurgical Associates in Laguna Hills, USA.
The two-piece design helps minimise disruption and keeps the spinous ligament intact. Six pyramidal cleats help ensure secure purchase of the plate to the spinous process and simple, intuitive instrumentation facilitates operating room efficiency while the square thread locking cap helps reduce potential for cross-threading. In addition, the Reli SP is available in a wide range of implant sizes so that adaptations can be made to take into account pathology, as well as each patient’s anatomy, conditions and predispositions,” Massoudi added.
The company also announced that its Reform pedicle screw system has received expanded indications from the FDA.
“The Reform system has been well-received in the surgeon community and we are confident that the system’s expanded indications will broaden both its usage and popularity,” said Rich Dickerson, president of Precision Spine.
Precision Spine announced a fifth consecutive year of double-digit growth for 2014. The company indicated that fourth quarter 2014 sales represented a 45% increase over fourth quarter 2013. Full year 2014 sales increased 26% over the prior year.
“To achieve double-digit growth for five consecutive years is a testament to our ability to consistently provide advanced, high quality products that successfully bring efficiency and cost-effectiveness to the treatment of a variety of spinal pathologies,” said Dickerson.
