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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

510(k)

Stryker clears the Sonopet 3 ultrasonic platform and starts cases this month

MedDevice Startups Staff · 6 days ago · 1 min read · Via MassDevice

Stryker has 510(k) clearance for Sonopet 3, the next version of its ultrasonic bone and soft tissue removal line. The platform adds pulse control, which gives the surgeon more say over how hard and soft tissue come away, and it ties into Stryker's RISE integration layer for the rest of the room.

Stryker says hundreds of surgeons shaped the design. Neurosurgical VP and general manager Mitch Foley said every major advancement in Sonopet 3 can be attributed to surgeon feedback, and that surgeons asked for "more power, improved ergonomics and enhanced integration." First cases are planned for this month, with a full commercial launch later in the fall.

Questions & Answers

What is the Stryker Sonopet 3?

Sonopet 3 is Stryker's ultrasonic platform for removing bone and soft tissue, cleared by FDA under a 510(k) in October 2026. It adds pulse control for modulating resection and connects to Stryker's RISE integrated surgical workflow.

When will the Stryker Sonopet 3 be available?

Stryker expects the first clinical cases with Sonopet 3 in October 2026 and a full commercial launch later in the fall.

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