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Home » Stryker earns FDA clearance for new bone and soft tissue removal platform

Stryker earns FDA clearance for new bone and soft tissue removal platform

October 15, 2026 By Skyler Rivera

A photo of Stryker's Sonopet 3 platform.
Sonopet 3 enhances the company’s Sonopet offerings. [Photo courtesy of Stryker]
Stryker (NYSE: SKY) earned FDA 510(k) clearance for its latest ultrasonic bone and soft tissue removal platform, Sonopet 3.

Sonopet 3 features enhancements to the company’s Sonopet offerings, such as pulse control, which gives providers added ability to regulate hard and soft tissue resection and Stryker’s Reimagined Integrated Surgical Experience (RISE) technology for a connected surgical workflow.

Stryker said it developed the advanced platform with input from hundreds of surgeons who informed key performance improvements, workflow efficiency and clinical priorities.

“At Stryker, innovation begins with listening to our customers,” Stryker Neurosurgical VP and GM Mitch Foley said in the announcement. “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,” he continued.

Read more about the world’s largest medtech companies in our 2026 Medtech Big 100 issue of Medical Design & Outsourcing

Stryker expects the first clinical cases using the platform to begin this month, with a full commercial launch planned for later this fall.

As the orthopedics company expands platforms like Sonopet, it recently invested $400 million in CMR Surgical and entered the soft-tissue robotics market. In the deal, Stryker gains exclusive rights to sell CMR’s Versius platform in the United States and has the option to acquire the company in the future.

Earlier this month, Stryker’s long-time CEO Kevin Lobo announced that he will step down, ending his more than 14-year tenure leading the company. Stryker Chief Operating Officer Spencer Stiles will become the company’s next CEO, and Lobo will continue to serve as executive chair.

Filed Under: 510(k), Business/Financial News, Featured, Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance, Surgical Tagged With: FDA, Stryker, Surgical tools

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About Skyler Rivera

Skyler Rivera is an associate editor at Arrowfly, covering medical device industry news and technology at MassDevice and Medical Design & Outsourcing. She began her career covering sports at The Athletic and MLB before transitioning to medical writing at Edwards Lifesciences. Based in Southern California, she holds a master's degree in science writing from Johns Hopkins University and a bachelor’s in broadcast journalism from Syracuse University. Connect with her on LinkedIn or email at [email protected].

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