Thursday, December 8, 2022

VySpine Announces FDA Clearance of the VySpan PCT System

VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for the VySpan Posterior Cervical Thoracic System.

The VySpan PCT System features various screw and hook options, multiple transition rods and revolutionary crosslink versatility. The variety of implant options for the thoracic spine makes the system one of the most versatile on the market.

“The VySpan PCT System is the first of many highly differentiated systems being developed by VySpine,” said Tom McLeer, CEO of 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.

The VySpan PCT System also offers a unique 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 for extraordinary versatility. Rod-to-rod connectors allow the VySpan PCT System to connect with larger Ø5.5mm and Ø6.0mm rods and includes transition rods, which taper from Ø3.5mm to either Ø5.5mm or Ø6.0mm.

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