Stryker spine guidance software earns FDA clearance

Stryker’s Q Guidance System with Spine Guidance 5 Software featuring Copilot has earned 510(k) clearance from the FDA. 

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The software is intended 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, according to a July 30 press release. 

Stryker worked with over 850 orthopedic spine and neurosurgeons to develop the 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, according to the release.

The Copilot Smart Driver then stops automatically when it reaches the planned depth to aid  surgeons with precision and accuracy 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 and a full commercial launch of the technology is expected later this fall.

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