Stryker’s Sonopet 3 ultrasonic platform receives FDA 510(k) clearance
The U.S. Food and Drug Administration has granted Stryker a 510(k) clearance for its Sonopet 3 ultrasonic platform, with first clinical cases expected in October 2026 and a commercial launch slated for later that fall.
16 Oct 2026 0 reads Compiled with AI
The FDA has cleared Stryker’s Sonopet 3 ultrasonic platform under the 510(k) pathway, allowing the company to begin first clinical cases this October and to prepare for a full commercial rollout later in the year. The clearance was announced by both Medical Device Network and PharmaShots, which noted the device’s use for bone and soft‑tissue removal during surgery.
Stryker built Sonopet 3 with input from hundreds of surgeons, resulting in a single‑system tool that offers enhanced power, precision and versatility. The platform includes Pulse Control, which lets surgeons regulate hard‑ and soft‑tissue resection, and RISE (Reimagined Integrated Surgical Experience), a software layer that connects surgical workflows across settings.
The design emphasis on integration and workflow efficiency is intended to give surgeons greater confidence in demanding operating rooms. Stryker’s broader portfolio spans MedSurg, Neurotechnology and Orthopaedics, and the new device strengthens its neurosurgical equipment lineup.