FDA OKs Stryker’s Q Spine Guidance System Software

Stryker has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Q Guidance System with Spine Guidance 5 software, featuring Copilot.

The technology integrates smart-powered instruments into Stryker’s portfolio. Spine Guidance Software with Copilot offers feedback modalities to support bone resection, pedicle preparation, and screw delivery.

The company said it worked with more than 850 spine surgeons and neurosurgeons to develop the technology.

Smart Zones for bone resection offer auditory and sensory feedback when the planned boundaries of anatomical alert zones are approached with the high-speed drill. The Copilot Smart Driver automatically stops when the planned depth is reached. The automatic depth stop feature is proprietary tech that unlocks only when using a Stryker implant.

“This project is a prime example of our mission in action,” said Dylan Crotty, president of Stryker’s Instruments division. “We listened to our customers’ evolving needs and are engaging leading surgeons to create a product that adds confidence to their workflow.” 

The company said the first clinical cases using Spine Guidance with Copilot will begin in September, with full commercial rollout later this fall.

“Spine Guidance Software with Copilot is just the beginning of our development pipeline,” said Robbie Robinson, president of Stryker’s Spine division. “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.”

Earlier this month, Stryker closed its acquisition of Artelon, a company that specializes in soft tissue fixation products for foot & ankle and sports medicine procedures.