FDA clears Zimmer Biomet’s robotic knee surgery system

Zimmer Biomet received a 510(k) clearance from the FDA for its robotic assistance platform for total knee replacement surgeries.

The Rosa knee system includes three-dimensional, preoperative planning tools, and provides data on soft-tissue and bone anatomy during the procedure to help improve cutting accuracy and implant alignment. It also performs real-time range-of-motion analyses to help balance soft tissue in the joint on a patient-specific basis.

"We are excited for the launch of Rosa Knee, which brings together Zimmer Biomet's robotics technology with our industry-leading knee implants to help surgeons personalize surgical procedures for their patients," Ivan Tornos, Zimmer Biomet’s group president of orthopedics, said in a statement.

The system uses the company's X-Atlas imaging protocol, using X-ray scans to build a 3D model and plan of a patient's bone anatomy. It also incorporates navigation tools from Zimmer Biomet’s larger Rosa Robotics platform, which includes brain- and spine-focused systems for neurosurgery.

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Zimmer Biomet acquired the Rosa system and dove into the robotic surgery space in 2016, with its purchase of French manufacturer Medtech for about $132 million.

Rosa Brain received an FDA clearance in 2012, and has been used to provide guidance in treatments for hydrocephalus, generalized dystonia, Parkinson’s disease and cavernoma. Meanwhile, Rosa Spine netted a CE mark in 2014 and an FDA clearance in 2016.