Stryker Receives FDA Clearance for Q Guidance System for Spine Applications

Rhea-AI Summary

Stryker has received 510(k) clearance from the U.S. Food and Drug Administration for its Q Guidance System. This advanced planning and intraoperative guidance system is designed for spine surgery, enabling both open and percutaneous procedures. The system features innovative software, versatile tracking options, and high-performance navigation technology. Notably, the Spine Guidance Software is the first of its kind cleared for use in pediatric patients aged 13 and older. Stryker aims to provide a comprehensive surgical platform across multiple specialties.

Positive

• Q Guidance System received FDA 510(k) clearance, enhancing Stryker's surgical offerings.
• First spine navigation software cleared for pediatric use, broadening market reach.
• Features advanced technology including gesture recognition and automatic image registration.
• Robust product pipeline suggests future growth opportunities across multiple specialties.

Negative

• None.

Innovative planning and intraoperative platform designed to be a procedural ecosystem for surgeons and their patients during image-guided surgery

KALAMAZOO, Mich.--(BUSINESS WIRE)-- Stryker (NYSE:SYK) today announced that its Q Guidance System received 510(k) clearance from the U.S. Food and Drug Administration. The System, when used with the Spine Guidance Software, is an advanced 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 pediatric patients aged 13 and older.

Stryker’s 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 built on the company’s 20 years of experience developing guidance technologies. Q Guidance features 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.

“The versatility of the Q Guidance System will help to streamline our technologies across multiple specialties such as cranial, spine, ENT and orthopaedics,” said Robbie Robinson, President of the 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.”

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 Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Content ID: QGS-PR-1_33501

View source version on businesswire.com: https://www.businesswire.com/news/home/20220531005360/en/

Andrea Sampson, Sampson Public Relations Group

562.304.0301

asampson@sampsonprgroup.com

Source: Stryker

FAQ

What is the significance of Stryker's Q Guidance System receiving FDA clearance?

The FDA clearance allows Stryker to market its Q Guidance System, enhancing its surgical technology offerings and potentially increasing revenue.

Who can use the Spine Guidance Software?

The Spine Guidance Software can be used for patients aged 13 and older, as it is the first spine navigation software approved for this demographic.

What are the key features of Stryker's Q Guidance System?

The Q Guidance System includes advanced tracking options, sophisticated software, gesture recognition, and compatibility with various imaging techniques.

How does the Q Guidance System impact surgical procedures?

The system aims to streamline surgical procedures by providing enhanced planning and navigation capabilities for spine surgeries.

What future developments are anticipated for Stryker's surgical systems?

Stryker plans to integrate robotics and intelligent handheld instruments into its surgical systems, enhancing functionality and value for surgeons.