Stryker obtains FDA 510(k) clearance for Sonopet 3 ultrasonic tissue removal platform
Stryker announced that the U.S. Food and Drug Administration granted 510(k) clearance for its new Sonopet 3 system, an ultrasonic device for bone and soft‑tissue removal. The platform was co‑developed with input from hundreds of surgeons and adds the RISE and Pulse Control technologies to improve power, precision and workflow integration. Initial patient cases are slated for October, with a broader market launch planned for later in the fall.
Why it matters
The clearance allows Stryker to commercialize Sonopet 3 in the United States, expanding its neurosurgery product portfolio and potentially increasing sales in the neurotechnology segment. The company expects the device to generate incremental revenue once the full launch occurs later this fall.
Key facts
- 1Stryker received FDA 510(k) clearance for Sonopet 3, its latest ultrasonic bone and soft‑tissue removal platform. stocktitan.net
- 2The device was developed with input from hundreds of surgeons. prnewswire.com
- 3Sonopet 3 incorporates the RISE and Pulse Control technologies. stocktitan.net
- 4First patient cases are planned for October 2026. prnewswire.com
- 5A full commercial launch is expected later in the fall of 2026. stocktitan.net
- 6Mitch Foley, vice president and general manager of Stryker's Neurosurgical business, said the product reflects surgeon feedback for more power, better ergonomics and enhanced integration. prnewswire.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.