The VySpan PCT System features several screw and hook options, multiple transition rods along with advanced crosslink flexibility
FDA approves VySpan PCT system. (Credit: kalhh from Pixabay.)
Medical technology firm VySpine has received the US Food and Drug Administration (FDA) 510(k) approval for its VySpan Posterior Cervical Thoracic (PCT) System.
The PCT System comes with several screw and hook options, multiple transition rods and advanced crosslink flexibility.
It features fixed and polyaxial head styles, each with a reduction option, that can be clamped with either standard or smooth shank bone screws and various hooks and rods.
Also, VySpan offers variety of implant options for the thoracic spine, which makes it one of the versatile systems on the market, said the company.
VySpine CEO Tom McLeer 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.”
According to the company, VySpan PCT System offers a combination of rod-to-rod and cross connectors, including a head-to-head double joint cross connector.
The rod-to-rod connectors would enable the system to connect with larger Ø5.5mm and Ø6.0mm rods and transition rods tapering from Ø3.5mm to Ø5.5mm or Ø6.0mm.
VySpine was established based on active internal development and the licensing of various proven technologies using innovative materials and designs.
The company’s core spine products and newly developed specialty products are said to address the needs of both health care providers and surgeons.
In July last year, VySpine has completed its FDA Establishment Registration process, which allows the company to seek FDA approvals for its products.