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

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

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

SourceStryker

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

0
Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

0
Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

0
Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

0
The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

0
“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”

About us

Medical Device News Magazine

Welcome to Medical Device News Magazine, a digital publication providing up to the minute medical device news and biotechnology news.

Need to know more?

Contact us

Navigation

Florida, New York
United States
Phone Number: 1.561.316.3330