Zimmer Biomet receives FDA 510(k) clearance for direct anterior THA system
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Zimmer Biomet Holdings Inc. announced it has received FDA 510(k) clearance for its Rosa Hip System for robotically-assisted direct anterior total hip replacement.
The Rosa Hip System – a fluoroscopy-based tool designed for surgeons who use the direct anterior approach – aims to assist with preparation, positioning and component impaction, while intraoperatively quantifying cup orientation, leg length and offset, according to a company press release. The release noted intraoperative data collected by the Rosa Hip System can be combined with pre- and postoperative data collected by mymoblity with Apple Watch and consolidated and analyzed by OrthoIntel Orthopedic Intelligence Platform, which was designed to uncover new clinical insights throughout the episode of care and help surgeons and care teams make informed decisions and optimize patient care.
“We are excited to announce the FDA clearance of Rosa Hip, and to now offer one of the most comprehensive orthopedic robotic solutions through a single, multiple application platform,” Ivan Tornos, chief operating officer at Zimmer Biomet, said in the release. “As an integrated component of our ZBEdge Connected Intelligence Suite, Rosa Hip advances our vision to translate pre-, intra- and postoperative data into actionable clinical insights to inform personalized care decisions.”
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