Stryker launches Sonopet® 3, delivering greater power and precision in ultrasonic tissue removal

The first clinical cases are expected in October, ahead of a full commercial launch anticipated later this fall.

Rhea-AI Summary

Stryker (SYK) has received FDA 510(k) clearance for Sonopet 3, its latest ultrasonic bone and soft tissue removal platform.

Developed with input from hundreds of surgeons, the platform includes RISE for connected surgical workflows and Pulse Control to regulate tissue removal. Stryker expects the first clinical cases in October, with a full commercial launch anticipated later this fall.

Positive

• Minor pointSonopet 3 received FDA 510(k) clearance for its ultrasonic bone and soft tissue removal platform.
• Minor point. Forward-looking: it has not happened yet and may not happen.Stryker expects first clinical cases in October and anticipates full commercial launch later this fall.

Negative

• None.

Key Figures

FDA clearance: 510(k) clearance First clinical cases: October Full commercial launch: Later this fall

FDA clearance

510(k) clearance

Sonopet 3

First clinical cases

October

Expected to begin using Sonopet 3

Full commercial launch

Later this fall

Anticipated for Sonopet 3

Key Terms

510(k) clearance, resection

2 terms

510(k) clearance regulatory

"received 510(k) clearance from the U.S. Food and Drug Administration"

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

resection medical

"provides an added ability to regulate the resection of hard and soft tissues"

Surgical removal of part or all of an organ, tumor, or other tissue. A resection can be partial or complete, performed through open or minimally invasive techniques, and typically results in the removed specimen being sent for pathological examination; the term describes the act of cutting out tissue rather than subsequent reconstruction or other therapies.

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• Stryker has received FDA 510(k) clearance for Sonopet® 3 , the latest evolution of its ultrasonic bone and soft tissue removal platform.
• Developed in collaboration with surgeons, Sonopet 3 delivers enhanced power, precision and versatility.
• Customers gain access to advanced technologies including RISE and Pulse Control, supporting streamlined workflows and integration across surgical settings.

PORTAGE, Mich., Oct. 14, 2026 /PRNewswire/ -- Stryker (NYSE: SYK), a global leader in medical technologies, announced today that Sonopet 3, its latest ultrasonic bone and soft tissue removal platform, has received 510(k) clearance from the U.S. Food and Drug Administration.

Developed with input from hundreds of surgeons, Sonopet 3 is designed to deliver enhanced power, precision and versatility in a single platform for tissue removal. Surgeon collaboration directly shaped the new platform, informing key improvements in performance, workflow efficiency and clinical priorities.

"At Stryker, innovation begins with listening to our customers," said Mitch Foley, vice president and general manager of Stryker's Neurosurgical business. "Every major advancement in Sonopet 3 can be attributed to surgeon feedback, and together we're elevating the standard in neurosurgery. They told us they wanted more power, improved ergonomics and enhanced integration, helping them perform with confidence in demanding surgical environments."

In addition to performance enhancements, Sonopet 3 provides access to the platform's latest technologies, including RISE, a Reimagined Integrated Surgical Experience for a connected surgical workflow, and Pulse Control, which provides an added ability to regulate the resection of hard and soft tissues. Together, these advancements help support integration across surgical workflows.

The first clinical cases using Sonopet 3 are expected to begin in October, with a full commercial launch anticipated later this fall.

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

Media contact
Stryker
Jenny Braga
Senior Director, External Affairs
jenny.braga@stryker.com

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SOURCE Stryker

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Has Stryker's Sonopet 3 received FDA clearance?

Sonopet 3 has received 510(k) clearance from the U.S. Food and Drug Administration. It is Stryker's latest ultrasonic bone and soft tissue removal platform.

When will Stryker launch Sonopet 3 commercially?

Stryker anticipates a full commercial launch later this fall. The first clinical cases using Sonopet 3 are expected to begin in October.