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FDA issues 510(k) for OrthoSensor knee arthroplasty sensor

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OrthoSensorThe FDA issued 510(k) clearance to OrthoSensor for its Verasense sensor-assisted technology, which the company says is the only single-use intelligent sensor that measures tibial coronal alignment and ensures soft-tissue balance.

The sensor is used during primary and revision total knee arthroplasty along with the Zimmer Biomet Persona knee implant system. It’s then discarded.

According to the Dania Beach, Fla.-based company, the sensor transmits real-time data to a display unit in the operating room, allowing surgeons to make more informed decisions about implant alignment and soft-tissue balance.

“The ability to achieve optimal knee stability, implant congruency and alignment through the full range of motion is critical,” said OrthoSensor chief medical officer Dr. Martin Roche, an orthopedic surgeon, in a news release. “The data that is provided from the single-use Verasense sensor will enable surgeons at hospitals and ambulatory surgery centers to make objective assessments intraoperatively of soft-tissue balance and knee alignment with the Persona implant system for the best possible patient outcomes.”

Company president & CEO Ivan Delevic called the clearance a “great milestone for OrthoSensor” which has “always been committed to quantifying orthopedics through sensor-assisted technology and enable healthcare providers globally with evidenced-based treatments that improve clinical and economic outcomes for patients and healthcare stakeholders.”

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