Stryker’s Q Guidance System for cranial applications receives FDA clearance

Rhea-AI Summary

Stryker (NYSE:SYK) announced FDA 510(k) clearance for its Q Guidance System with Cranial Guidance Software, enhancing surgical procedures in cranial operations. The system is designed for computer-assisted planning, providing real-time guidance by tracking instruments in patient images. This innovative software is aimed at improving surgical accuracy and confidence, marking a significant advancement in cranial navigation technology. Additionally, the system supports varied surgical instruments and new workflows for brain biopsies.

President Robbie Robinson emphasized the importance of this milestone for transforming cranial surgery and reaffirmed Stryker's commitment to advanced navigation products.

Positive

• Stryker received FDA 510(k) clearance for the Q Guidance System with Cranial Guidance Software, enhancing surgical precision.
• The system supports a range of instruments for navigated cranial procedures.
• The software introduces new workflows for improved accuracy in brain biopsies.

Negative

• None.

Cranial Guidance Software offers surgeons robust imaging and guidance during cranial procedures

KALAMAZOO, Mich.--(BUSINESS WIRE)-- Stryker (NYSE:SYK), one of the world’s leading medical technology companies, today announced that its Q Guidance System with Cranial Guidance Software received 510(k) clearance from the U.S. Food and Drug Administration. The Q Guidance System is an image-based planning and intraoperative guidance system designed to support cranial surgeries. Recently launched in September 2022, the Q Guidance System for spinal applications is currently available on the market.

The Q Guidance System with Cranial Guidance Software is indicated for any medical condition in which the use of computer-assisted planning and surgery may be appropriate and can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. It tracks navigated instruments and displays the position and orientation of the instruments in patient images. The Cranial Guidance Software includes automatic, algorithmic processing and comprehensive guidance data that aim to elevate confidence and surgical ability.

“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.”

The Cranial Guidance Software is powered by Stryker’s Q Guidance System and can be used with a range of instruments and accessories for navigated cranial procedures. New for brain biopsies, the software provides a dedicated workflow to support the accurate alignment of the Precision Targeting System with a pre-operatively planned approach. Stryker is also leveraging plug-in EM tracking technology that can be used with both adults and pediatric patients for the placement of shunt catheters, which can be visualized with an EM Stylet.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.

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Andrea Sampson, Sampson Public Relations Group

562 304 0301

asampson@sampsonprgroup.com

Source: Stryker

FAQ

What is the significance of Stryker's FDA clearance for the Q Guidance System with Cranial Guidance Software?

The FDA clearance indicates that the Q Guidance System is approved for use in cranial surgeries, enhancing surgical efficiency and accuracy.

When was the Q Guidance System with Cranial Guidance Software launched?

The Q Guidance System was launched in September 2022 for spinal applications, now receiving clearance for cranial procedures.

How does the Q Guidance System improve cranial surgery?

It provides real-time imaging and navigation for surgical instruments, aiming to increase confidence and precision during procedures.

What types of procedures can benefit from the Cranial Guidance Software?

The software can be used for any medical condition requiring computer-assisted surgical planning, including brain biopsies.