Zimmer Biomet Receives FDA Approval for ROSA ONE Spine Robotic System to Assist in Minimally Invasive Spinal Surgery

VCBeat (WeChat Official Account: vcbeat) learned from foreign media that on March 25, U.S. local time, Zimmer Biomet, headquartered in Warsaw, Indiana, announced that its ROSA ONE Spine robotic system had received FDA approval for use in assisting minimally invasive spine surgery. The addition of the ROSA ONE Spine system also enriches Zimmer Biomet’s product portfolio, which includes ROSA ONE Brain and ROSA Knee.

Zimmer Biomet is a global leader in musculoskeletal healthcare, helping patients with conditions affecting bones, joints, or supporting soft tissues return to normal lives. The company also manufactures and sells orthopedic medical products, including biologics, dental implants, spinal, craniomaxillofacial, and thoracic products, operating in more than 25 countries worldwide and selling its products in over 100 countries.

ROSA ONE Spine is a robotic surgical navigation system dedicated to assisting surgeons in performing minimally invasive and complex thoracolumbar spine procedures. By integrating robotic guidance with navigation capabilities, ROSA ONE Spine operates seamlessly and flexibly at the surgeon’s discretion, enabling clinicians to focus on surgical objectives and enhance patient outcomes. Furthermore, the ROSA ONE Spine robot incorporates “dynamic tracking” technology, which allows both the robot and the patient to move simultaneously while maintaining accurate targeting of the pathological site, without the need for attachment to the operating table.

In the United States, more than one-quarter of adults experience back pain at least once a day, making it one of the most common medical issues in American society. The spinal column is a complex structural organization, with each segment corresponding to different functions, including neural transmission, motor control, and supporting the head. Back pain can significantly impair an individual’s daily life. Typically, physicians prefer non-surgical conservative treatments as the first-line approach for back pain; however, if conservative management fails, Zimmer Biomet offers a range of surgical treatment options through its ROSA ONE Spine system.

Currently, ROSA ONE Spine can be used on the same platform as Zimmer Biomet’s 510(k)-cleared ROSA ONE Brain and ROSA Knee systems. This platform is the only robotic hardware platform on the market capable of treating neurosurgical, spinal, and knee pathologies. The launch of the ROSA ONE Spine system expands the applications of Zimmer Biomet’s ROSA ONE Brain system and its flagship product, ROSA Knee.

Zimmer Biomet’s medical devices cover a wide range of anatomical sites. In addition to the aforementioned ROSA ONE Spine, ROSA ONE Brain, and ROSA Knee, Zimmer Biomet’s orthopedic portfolio also extends to the hip, shoulder, elbow, thorax, and other areas.

Zimmer Biomet Medical Device Product Schematic (Image Source: Official Website)

Zimmer Biomet was founded in 1927 and was listed on the New York Stock Exchange (NYSE: ZBH) on August 3, 2001.

(Compiled by: Wang Chan)