FDA approves Zimmer Biomet’s ROSA ONE Spine system

27 March 2019 (Last Updated March 27th, 2019 09:23)

Zimmer Biomet has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ROSA ONE Spine System in robotically assisted surgeries.

FDA approves Zimmer Biomet’s ROSA ONE Spine system
Zimmer Biomet develops surgical systems, orthopaedic reconstructive and sports medicine products. Credit: Zimmer Biomet.

Zimmer Biomet has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its ROSA ONE Spine System in robotically assisted surgeries.

The company’s craniomaxillofacial (CMF) and thoracic and surgery assisting technology group president Aure Bruneau said: “ROSA ONE Spine functions as a dual robotics and navigation technology solution for minimally invasive and complex thoracolumbar spine procedures.”

ROSA ONE Spine’s surgical navigation system features a real-time patient tracking capability and 3D intra-operative planning software for improved implant placement.

“ROSA ONE Spine functions as a dual robotics and navigation technology solution for minimally invasive and complex thoracolumbar spine procedures.”

The new device expands the company’s suite of ROSA ONE systems, offers treatment of neurosurgical, spinal and knee pathologies in one platform.

The FDA cleared ROSA ONE Knee in January this year for use in robotically assisted total knee replacements. This device features 3D pre-operative planning tools and real-time, intraoperative data on soft-tissue and bone anatomy.

The knee surgery device is intended to improve bone cut accuracy and a range of motion gap analyses to potentially boost flexion and restore natural joint movement.

ROSA ONE Brain received US regulatory clearance in February for neurosurgical minimally invasive procedures such as biopsies and deep brain stimulation.

In addition to surgical systems, Zimmer Biomet portfolio includes orthopaedic reconstructive, sports medicine, extremities and trauma products, among other medical devices.