Stryker nets FDA clearance for Q Guidance

2020 02 24 17 44 7728 Clearance Stamp 400

Orthopedic device developer Stryker has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its Q Guidance spine surgery navigation software.

Designed to facilitate open or percutaneous computer-assisted surgery, Q Guidance provides planning and intraoperative guidance via multiple tracking options, software algorithms, and "smart" instrumentation, according to the company. It features a navigation camera, redesigned software applications, semiautomated and automated segmentation features, gesture recognition, and compatibility with various types of image sets, Stryker said.

Q Guidance provides automated image registration when used with Stryker's Airo TruCT mobile CT scanner, according to the vendor. It has also been cleared for use in pediatric patients ages 13 and older.

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