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FDA Clears Zimmer Biomet's Rosa One Spine System

Against the odds, Zimmer Biomet is the first company to gain FDA clearance for brain, spine, and knee offerings on one robotic platform.

Zimmer Biomet is sliding into the surgical robotics market just in time. The company now has FDA clearance for brain, spine, and knee offerings on one robotic platform.

FDA has cleared Zimmer Biomet's Rosa One Spine System, making the company the first to gain FDA clearance for brain, spine, and knee offerings on one robotic platform.

The milestone follows on the heels of the Warsaw, IN-based company scoring FDA clearance earlier this year for the Rosa Knee System to be used in robotically-assisted replacement procedures.

Surgical robotics is hotter than ever in 2019, particularly on the orthopedics side, and Zimmer Biomet is sliding into the market just in time. But don't expect the company to rush into a full commercial launch with this technology. CEO Bryan Hanson previously said the company plans to take things slow with its robot.

"We're going to do a limited launch out of the gate," Hanson said during the company's fourth-quarter earnings call, as transcribed by Seeking Alpha. "We want to be very disciplined in our approach to launching a new robotic system to make sure that we do it right. We have the right education. We have the right service levels. And we will do that limited launch for, let's call it six months. Post that limited launch is when we move into full launch. And that's when the organization gets unleashed and we utilize that technology in that full launch status."

The platform features 3D intraoperative planning software in addition to a navigation suite of technologies designed to improve implant as well as instrument placement accuracy and predictability.

"Rosa One Spine functions as a dual robotics and navigation technology solution for minimally invasive and complex thoracolumbar spine procedures," said Aure Bruneau, Zimmer Biomet's group president of Spine, CMF and Thoracic and Surgery Assisting Technology. "We are extremely excited about the addition of Rosa One Spine to our already released Rosa One Brain and Rosa Knee Systems."

Rosa's dynamic tracking functionality is designed to allow the robot to move with the patient, providing accuracy without the need to be attached to the patient or the surgical table. The multi-function robot can increase the utilization of the robotic platform within the neurosurgical and orthopedic department, decreasing technology acquisition costs and streamlining service, repair, and education, the company said.

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