Stryker's Spine Guidance 5 Software featuring Copilot receives 510(k) clearance from FDA

Rhea-AI Summary

Stryker (NYSE:SYK) has received FDA 510(k) clearance for its Q Guidance System with Spine Guidance 5 Software featuring Copilot. This first-to-market technology integrates smart-powered instruments into Stryker's ecosystem, providing multiple feedback modalities for bone resection, pedicle preparation, and screw delivery. The system includes Smart Zones for bone resection and the Copilot Smart Driver with automatic depth stop for pedicle preparation and screw placement.

Developed with input from over 850 surgeons, this technology aims to enhance surgeon effectiveness and improve patient outcomes. The first clinical cases are set to begin in September, with a full commercial launch expected in fall 2024.

Positive

• FDA 510(k) clearance received for Q Guidance System with Spine Guidance 5 Software
• First-to-market technology integrating smart-powered instruments
• Developed with input from over 850 orthopaedic spine surgeons and neurosurgeons
• Automatic depth stop feature is proprietary technology
• Clinical cases to begin in September with full commercial launch expected in fall 2024

Negative

• None.

Q Guidance System with Spine Guidance 5 Software featuring Copilot is a first-to-market technology, pioneering new planning and surgical capabilities

LEESBURG, Va. , July 30, 2024 /PRNewswire/ -- Stryker (NYSE:SYK), a global leader in medical technologies, today 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.

"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."  

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.

"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."

The first clinical cases using Spine Guidance Software with Copilot will begin in September, with a full commercial launch expected later this fall. For more information on Spine Guidance Software with Copilot please visit https://www.stryker.com/us/en/nse/products/spine-guidance-software-copilot.html.

*Smart features enabled by the Q Guidance System with Spine Guidance 5 Software.
**SPINE-COP-BROC-1169302

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at www.stryker.com.  

Media contact
Sarah Yerden
509 438 1198
sarah.yerden@stryker.com

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SOURCE Stryker

FAQ

What is Stryker's newly FDA-cleared Spine Guidance 5 Software featuring Copilot?

Stryker's Spine Guidance 5 Software featuring Copilot is a first-to-market technology that integrates smart-powered instruments into Stryker's ecosystem. It provides multiple feedback modalities for bone resection, pedicle preparation, and screw delivery to enhance surgeon effectiveness and patient outcomes.

When will Stryker (SYK) begin clinical cases using the new Spine Guidance Software with Copilot?

Stryker plans to begin the first clinical cases using Spine Guidance Software with Copilot in September 2024, with a full commercial launch expected later in the fall of 2024.

What are the key features of Stryker's (SYK) new Spine Guidance 5 Software?

Key features include Smart Zones for bone resection providing auditory and sensory feedback, and the Copilot Smart Driver with automatic depth stop for pedicle preparation and screw placement. The system aims to support surgeon precision and enhance patient outcomes.

How many surgeons were involved in developing Stryker's (SYK) new Spine Guidance technology?

Stryker engaged over 850 orthopaedic spine surgeons and neurosurgeons in developing the Spine Guidance 5 Software featuring Copilot technology.