Zimmer Biomet Gains FDA Clearance of ROSA ONE Spine System for Robotically-Assisted Surgeries

By Julie A. Vetalice

Zimmer Biomet (ZBH) received FDA 510(k) clearance to market the ROSA® ONE Spine System for robotically-assisted minimally invasive and complex spine surgeries. The company now has 510(k) clearance for brain, spine and knee offerings on one robotic platform.

ROSA ONE Spine combines robotics and navigation while delivering real-time patient dynamic tracking that allows the robot to move with the patient. It features 3D intraoperative planning software and navigation to support implant and instrument placement accuracy and predictability.

Analysts at Wells Fargo anticipate that the spine application could contribute up to $15MM to ZBH sales in 2019. They noted that with this clearance, the company can now offer brain and spine on a single platform, while the knee application remains on a different chassis, though ZBH may integrate all knee, spine and brain onto one platform in the future. The company has an installed base of 100 ROSA systems in the U.S., currently.

The ROSA Knee application, which received FDA clearance in January 2019, will enter limited launch within 1H19.

Sources: Zimmer Biomet, Inc.; Wells Fargo Securities; ORTHOWORLD Inc.

Product Labels: Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory