VySpine has received 510(k) clearance from the US Food and Drug Administration (FDA) for the VySpan posterior cervical thoracic (PCT) system. The system features various screw and hook options, multiple transition rods and, according to the company, revolutionary crosslink versatility.
Tom McLeer, CEO of VySpine, said: “The VySpan PCT system is the first of many highly differentiated systems being developed by VySpine. Using new materials and creative surgeon input, we are building exceptional quality, flexibility, and pricing into all our products. This is just the beginning of the exciting, innovative product launches scheduled for early 2022.”
The VySpan PCT system features fixed and polyaxial head styles, each with a reduction option, that can be paired with either standard or smooth shank bone screws and a variety of hooks and rods.
It also offers an assortment of rod-to-rod and cross connectors, including a novel head-to-head double joint cross connector, as well as three- and four-point cross connectors. Rod-to-rod connectors allow the VySpan PCT system to connect with larger Ø5.5mm and Ø6mm rods and includes transition rods, which taper from Ø3.5mm to either Ø5.5mm or Ø6mm.