The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stryker for Sonopet 3, the medical technology company’s latest ultrasonic platform for bone and soft tissue removal.
Following the regulatory decision, the device is scheduled for use in its first clinical cases this month, ahead of an anticipated full commercial rollout later this autumn.
Developed as a single system for surgical tissue excision, Sonopet 3 was created in collaboration with hundreds of surgeons.
According to the company, direct feedback from clinicians informed key refinements to the device, shaping improvements in workflow efficiency, clinical priorities and performance to deliver greater precision, power and versatility.
Stryker Neurosurgical business vice president and general manager Mitch Foley said: “At Stryker, innovation begins with listening to our customers. 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.”
The platform incorporates several technological additions designed to assist integration across clinical settings and streamline surgical procedures.
These include Pulse Control, which enables surgeons to regulate hard- and soft-tissue resection, and RISE, a Reimagined Integrated Surgical Experience, which connects surgical workflows.
Commercial distribution is expected to expand following the initial procedural cases scheduled for this month.
In addition to its neurosurgical offerings, Stryker provides medical equipment and healthcare services across the MedSurg, Neurotechnology and Orthopaedics sectors.
Earlier this week, Stryker invested $400m into a partnership with CMR Surgical to broaden its presence in the surgical robotics sector.
The funding aims to support US commercialisation activities for CMR’s Versius robotic surgery platform, whilst also creating a pathway for Stryker to acquire the company in the future.
