Stryker receives FDA clearance for Spine Guidance Software

The Spine Guidance Software with Copilot is intended to support bone resection, pedicle preparation, and screw delivery.

Archana Rani July 31 2024

Stryker has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Q Guidance System with Spine Guidance 5 Software featuring Copilot.

This technology is the first on the market to integrate smart-powered instruments into the company’s expanding ecosystem.

The Spine Guidance Software with Copilot is designed to support bone resection, pedicle preparation, and screw delivery, providing multiple feedback modalities to optimise a surgeon's effectiveness and improve patient outcomes.

More than 850 orthopaedic spine surgeons and neurosurgeons collaborated with Stryker to develop this technology.

The software's Smart Zones offer auditory and sensory feedback to alert surgeons as they approach the planned boundaries of anatomical alert zones with the high-speed drill.

The Copilot Smart Driver complements this feature by automatically stopping at the planned depth, aiding surgeon precision at the time of pedicle preparation and screw placement.

Clinical cases using the Spine Guidance Software with Copilot are set to commence in September 2024.

Stryker is planning for a full commercial launch of the Spine Guidance Software with Copilot later this year.

Stryker spine division president Robbie Robinson said: “Spine Guidance Software with Copilot is just the beginning of our development pipeline.

“While focusing on innovation and the integration of our implants, instrumentation and enabling technologies, we strive to help surgeons perform safe and efficient procedures that enable better patient outcomes.”

Last month, Stryker launched the LIFEPAK 35, its latest product in the monitor / defibrillator space.

Built on an intuitive, modern platform to help advance patient care, the device is designed to support life-saving teams by providing real-time access to critical patient information.

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