Stryker's spine guidance 5 software 510(k) U.S. FDA clearance

30th July, 2024

Software featuring Copilot is a first-to-market technology, pioneering new planning and surgical capabilities

Stryker announced that its Q Guidance System with Spine Guidance 5 Software featuring Copilot received 510(k) clearance from the U.S. Food and Drug Administration. This first-to-market technology seamlessly integrates smart-powered instruments into Stryker's growing ecosystem.

Spine Guidance Software with Copilot's breakthrough technology was built to provide multiple feedback modalities for supporting bone resection, pedicle preparation and screw delivery to help maximize a surgeon's effectiveness and enhance patient outcomes. Stryker engaged over 850 orthopaedic spine surgeons and neurosurgeons to develop this technology.

Smart Zones for bone resection provide auditory and sensory feedback when surgeons approach the planned boundaries of anatomical alert zones with the high-speed drill. To complement Smart Zones, the Copilot Smart Driver stops automatically when it reaches the planned depth, supporting surgeon precision during pedicle preparation and screw placement. The automatic depth stop feature is proprietary technology that unlocks only when using a Stryker implant.

The first clinical cases using Spine Guidance Software with Copilot will begin in September, with a full commercial launch expected later this fall.