FDA clears cranial procedure guidance system from Stryker

Stryker announced today that it received FDA 510(k) clearance for its Q Guidance System with cranial guidance software.

Kalamazoo, Michigan-based Stryker designed the Q Guidacne System as an image-based planning and intraoperative platform. The company launched the system for spinal applications in September 2022. This latest iteration offers support for cranial surgeries.

Q Guidance with cranial guidance software is in computer-assisted planning and surgery. Its uses include intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system tracks navigated instruments and displays the position and orientation of instruments in patient images.

Stryker designed the system with automatic, algorithmic processing and comprehensive guidance data. It said in a news release that it aims to elevate confidence and surgical ability.

The system can operate with a range of instruments and accessories for navigated cranial procedures. Its software provides a dedicated workflow to support the accurate alignment of the Precision Targeting System for brain biopsies.

Stryker said it also leverages plug-in electromagnetic tracking technology for use with both adult and pediatric patients. An EM Stylet can help visualize the placement of shunt catheters in these instances.

“The FDA clearance of Stryker’s Q Guidance System with cranial guidance software is a key milestone, which will help lead the transformation of cranial navigation and surgery,” said Robbie Robinson, president of Stryker’s Spine division. “Our robust pipeline of iterative launches reinforces our commitment to making industry-leading investments focused on providing advanced navigation products and differentiated technologies that our surgeon customers have come to expect.” MassDevice