June 12, 2018
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OrthoSensor receives FDA 510(k) clearance for sensor-assisted technology for knee system

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OrthoSensor Inc. announced it received FDA 510(k) clearance for the Verasense sensor-assisted technology, which intended to be used with Zimmer Biomet’s Persona Knee System for total knee replacement.

“Receiving FDA clearance for Verasense use with the Zimmer Biomet Persona Knee System, augments this outstanding implant and instrumentation, securing a better-balanced knee after surgery,” Ivan Delevic, president and CEO of OrthoSensor Inc., said in the release. “The Verasense device brings real-time, quantified soft tissue balance data to our surgeons. This evidenced-based data regarding soft tissue balance works with systems such as Persona so that surgeons can make objective assessments intraoperatively, resulting in better clinical outcomes for patients.”

According to the release, OrthoSensor received clearance in Australia to use the Verasense with the Persona Knee System. In a prospective multicenter study, Verasense was linked with decreased postoperative pain, accelerated patient activity levels, improved functional outcome and increased patient satisfaction scores.

Reference:

www.orthosensor.com