Stryker's Sonopet 3 Ultrasonic Surgical System Cleared by FDA
Stryker received FDA 510(k) clearance for Sonopet 3, an updated ultrasonic platform for removing bone and soft tissue during surgery. The system was developed with surgeon input and includes RISE for connected surgical workflows and Pulse Control for regulating hard and soft tissue resection. Initial clinical cases are expected in October 2026, with a broader commercial launch planned later in the fall.
Stryker, a Portage, Michigan-based medical technology company, has secured FDA 510(k) clearance for Sonopet 3. The device is an updated ultrasonic system intended to remove bone and soft tissue during surgery, with design input from hundreds of surgeons.
The platform adds RISE, a connected-workflow technology, and Pulse Control, a resection-regulation feature for hard and soft tissues. Stryker expects initial clinical use in October 2026, followed by wider commercial availability later that fall.
If adopted, Sonopet 3 may affect neurosurgeons and surgical teams by potentially streamlining tissue removal and connected workflow tasks. Patients could benefit if greater precision and control translate into safer or more efficient procedures, though actual clinical outcomes will depend on training, hospital adoption, and real-world performance. Hospitals and device purchasers may weigh cost, integration, and workflow fit. These are possibilities, not established results.