FDA clears Stryker Sonopet 3 ultrasonic surgical tissue removal platform
The FDA has cleared Stryker's Sonopet 3 ultrasonic surgical platform, introducing enhanced bone and soft-tissue removal capabilities for surgical procedures.
The Sonopet 3 system incorporates updated ultrasonic tissue removal technology with enhanced power, precision and surgeon-controlled features, including RISE workflow integration and Pulse Control.
Initial clinical use is expected in October 2026, with broader commercial availability planned later in the autumn, following the FDA's 510(k) clearance.
Field | Content |
Article Type | Approvals |
Device Name | Sonopet 3 |
Company | Stryker |
Regulatory Authority | U.S. Food and Drug Administration |
Regulatory Decision | 510(k) clearance |
Device Type | Ultrasonic surgical tissue removal system |
Clinical Application | Ultrasonic bone and soft-tissue removal during surgery |
Technology | Ultrasonic surgical tissue removal |
Key Features | Enhanced power and precision; surgeon-controlled functionality; RISE workflow integration; Pulse Control |
Workflow Feature | RISE workflow integration |
Control Feature | Pulse Control |
Therapeutic Area | Surgical technology; medical devices |
Geography | United States |
Initial Clinical Use | Expected October 2026 |
Broader Commercial Availability | Planned for later autumn 2026 |
What Happened | The FDA granted 510(k) clearance for Stryker's Sonopet 3 ultrasonic surgical platform. |
Why It Matters | The clearance enables introduction of an updated surgical platform designed to support controlled removal of bone and soft tissue. |
Potential Impact | Enhanced surgical control and workflow features may support adoption in procedures requiring precise ultrasonic tissue removal. |
Regulatory Context | Medical device clearance rather than pharmaceutical marketing authorisation |
Key Takeaway | Stryker's Sonopet 3 has secured FDA 510(k) clearance ahead of planned US clinical use and commercial rollout. |
What to Watch | Initial clinical deployment, commercial availability, surgeon feedback, adoption rates and future procedural performance evidence. |
Primary Source | Stryker |
Relevant Date | 14 October 2026 |
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