Stryker Gains 510(k) for Q Guidance System for Spine

By Julie A. Vetalice

Stryker Gains 510(k) for Q Guidance System for Spine

Stryker received FDA 510(k) clearance to market the Q Guidance System. When used with Spine Guidance Software, the system provides advanced planning and intraoperative guidance designed to enable open or percutaneous computer-assisted surgery. The Spine Guidance Software is reportedly the first spine navigation software to receive clearance from 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, software algorithms and smart instrumentation. 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 the Airo TruCT mobile CT scanner, this ecosystem delivers automatic image registration and pairs high performance tracking capabilities with high 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.”

Source: Stryker

Product Labels: Surgical Navigation

Tags: 510(k) Clearance, Regulatory