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FDA Grants Clearance for Stryker Q Guidance System for Spine Applications

StrykerQ 400x275

May 31, 2022

Stryker, which develops medical technologies in orthopedics, neurotechnology and spine applications, has announced that its Q Guidance System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). When used with Stryker’s Spine Guidance Software, the Q system is an advanced planning and intraoperative guidance system that can enable open or percutaneous computer-assisted surgery.

Stryker said the Spine Guidance Software is the first spine navigation software to receive clearance from the FDA for use with pediatric patients aged 13 and older. The system aims to deliver surgical spine planning and navigation capability through multiple tracking options, software algorithms and smart instrumentation. It includes a high-performance navigation build on the company’s 20 years of experience developing guidance technology, the company added. Q Guidance features redesigned software applications, semi-automatic and automatic segmentation features, gesture recognition, and is compatible with several types of image sets. When used with Airo TruCT mobile CT scanner, the system can deliver automatic image registration and pair high-performance tracking capabilities with intraoperative image quality and scan volume.

“The versatility of the Q Guidance System will help to streamline our technologies across multiple specialities such as cranial, spine, ENT and orthopedics,” said Robbie Robinson, president of Stryker’s spine division. “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.”

For more details on the system, visit the Stryker website here.


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