Stryker has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Q Guidance System with Cranial Guidance Software.
The US-based medical technology company has designed the image-based planning and intraoperative guidance system to support cranial surgeries.
The firm introduced the Q Guidance System for spinal applications in September 2022.
According to Stryker, the Q Guidance System with Cranial Guidance Software is authorised to be used in all medical conditions for which computer-assisted planning and surgery are suitable.
The combination can also be utilised for intraoperative guiding where a reference to a rigid anatomical structure can be recognised, the medical technology firm said.
It records instruments that are being moved and shows their location and orientation in images of the patient.
Stryker said that the Cranial Guidance Software aims to increase surgical proficiency and confidence through automatic, algorithmic processing and complete guiding data.
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.”
The Q Guidance System powers the Cranial Guidance Software, which can be used with a range of tools and accessories for guided cranial procedures.
The software offers a special workflow for brain biopsies that aids the precise alignment of the Precision Targeting System with a preoperatively prepared approach, the medical technology firm claimed.
According to Stryker, it also uses electromagnetic (EM) plug-in tracking technology for both adult and paediatric patients. In these situations, an EM Stylet can aid in visualising where to insert the shunt catheters.
In December last year, the company launched its new Citrefix suture anchor system for foot and ankle surgical procedures.
