Medical technology firm Stryker has secured 510(k) clearance from the US Food and Drug Administration for its Q Guidance System with Cranial Guidance Software for cranial applications.
The Q Guidance System is an image-based planning and intraoperative system. Its Cranial Guidance Software offers robust imaging and guidance to surgeons during cranial procedures.
Last September, Stryker launched the Q Guidance System for spinal applications. It is currently available on the market.
Stryker Spine division president Robbie Robinson said: “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.
“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.”
Stryker claims that the Q Guidance System with Cranial Guidance Software can be used to treat all medical conditions that are suitable for computer-assisted planning and surgery.
It can also be used for intraoperative guidance when rigid anatomical structures can be recognised and referenced.
Furthermore, the Q Guidance System with Cranial Guidance Software records instrument movements and can show their orientation and location in images of the patient.
The Cranial Guidance Software features automatic, algorithmic processing and complete guiding data.
It offers a workflow for brain biopsies to aid the Precision Targeting System’s precise alignment with a pre-operatively prepared approach.
Last December, Stryker launched its new Citrefix suture anchor system for foot and ankle surgical procedures.