Stryker has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Q Guidance System, which—when used with the company’s Spine Guidance Software—is a planning and intraoperative guidance system designed to enable open or percutaneous computer-assisted surgery.
The Spine Guidance Software is the first spine navigation software to receive clearance from the FDA for use with paediatric patients aged 13 and older, say Stryker.
According to a company press release, the Q Guidance System aims to deliver surgical spine planning and navigation capability through multiple tracking options, sophisticated software algorithms and smart instrumentation. It features a high-performance navigation camera as well as completely redesigned software applications, semi-automatic and automatic segmentation features, gesture recognition, and broad compatibility with various types of image sets.
When used with Airo TruCT mobile CT scanner, this ecosystem delivers automatic image registration and pairs high performance tracking capabilities with cutting edge intraoperative image quality and scan volume, Stryker say.
Robbie Robinson, president of Stryker’s spine division, said: “The versatility of the Q Guidance System will help to streamline our technologies across multiple specialties such as cranial, spine, ENT and orthopaedics.
“The system is designed for future compatibility with a fully integrated ecosystem, driving more value for our customers. With a robust product pipeline in place, we are positioned to provide a well-rounded, end-to-end platform for our surgeon customers, with the ability to incorporate robotics and intelligent handheld instruments in the future.”
