Zimmer Biomet Gains FDA Clearance for ROSA Hip System

By Julie A. Vetalice

Zimmer Biomet Gains FDA Clearance for ROSA Hip System

Zimmer Biomet announced FDA 510(k) clearance of the ROSA® Hip System for robotically-assisted direct anterior total hip replacement. ROSA Hip, the fourth robotic system introduced by Zimmer Biomet, adds to the company's ROSA Robotics portfolio which includes the ROSA Knee System for total knee arthroplasty, ROSA Partial Knee for partial knee arthroplasty and ROSA ONE® for neurosurgical and spine procedures. ROSA Hip is the newest addition to ZBEdge, Zimmer Biomet's suite of integrated digital and robotic technologies engineered to deliver transformative data-powered clinical insights, shared seamlessly across the patient journey.

Designed to seamlessly adapt to a surgeon's existing workflow, ROSA Hip aims to assist direct anterior surgeons with preparation, positioning and component impaction, while intra-operatively quantifying cup orientation, leg length and offset. Intra-operative data collected by ROSA Hip is combined with pre- and post-operative data collected by mymobility® with Apple Watch®, a proprietary remote care management platform, and it is seamlessly consolidated and analyzed by OrthoIntel Orthopedic Intelligence Platform, which is designed to uncover new clinical insights throughout the episode of care and help surgeons and care teams make informed decisions and optimize patient care.

ROSA Hip is designed for compatibility with multiple implant systems, including the Avenir Complete® Hip which, together with the G7® Acetabular System, aims to deliver greater operative flexibility to help surgeons address the distinct needs of each patient.

ROSA Hip is a fluoroscopy-based tool designed for surgeons who use the direct anterior approach, a minimally invasive approach to performing total hip replacement surgery. In addition to providing robotic assistance to guide accurate acetabular component orientation, as well as intra-operative assessment of leg length and offset, the application allows surgeons to create a personalized surgical plan through the use of ONE Planner™ Hip. This pre-operative planner features a spinopelvic mobility assessment tool if both a sitting and standing lateral X-ray are provided with the anteroposterior X-ray, together with an auto-plan function that allows surgeons to potentially create a pre-operative plan within five minutes. ROSA Hip may also help improve procedural efficiency with a simplified set-up that doesn't require pins or reference arrays and the convenient option to use X-ray imaging instead of CT scans.

Source: Zimmer Biomet

Product Labels: Hip Replacement, Robot-Assisted Systems

Tags: 510(k) Clearance, Regulatory