On August 18, 2021, Zimmer Biomet Holdings, Inc., announced FDA 510(k) clearance for its ROSA® Hip System for robotically-assisted direct anterior total hip replacement.
Technically called ONE Planner Hip in FDA clearance documents, the system is a medical imaging management and processing system intended for use as preoperative surgical planning software “to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.”
System Functions
According to the FDA clearance documents, the fluoroscopic-based system is an interactive software application which “enables 2D sizing and positioning of implants in the patient’s anatomy, calculates biomechanical measurements and performs functional analysis based on the patient’s pelvic kinematics.”
The biomechanical measurements relate to leg length and femoral offset. The functional analysis includes determination of pelvic parameters (e.g., pelvic tilt), and cup orientation calculations. The software application consists of an automated templating system and a web-based templating user interface.
The intra-operative data collected by the system is combined with pre- and post-operative data collected by mymobility® with Apple Watch® and consolidated and analyzed by the company’s OrthoIntel Orthopedic Intelligence Platform.
The system can be used with the following implant systems:
- G7 Acetabular Systems
- Taperloc Complete Stems
- Echo Bi-Metric Stems
- Avenir Complete
- Avenir Muller and Cemented Hip Stems
The company said the system features a “simplified set-up that doesn’t require pins or reference arrays, and it can be used with X-ray images instead of CT scans.” The company also said the system is the latest addition to ZBEdge, Zimmer Biomet’s suite of digital robotic technologies. Other systems include the ROSA Knee System for total knee arthroplasty, ROSA Partial Knee System for partial knee arthroplasty and ROSA ONE for neurosurgical and spine procedures.
This is the fourth robotic system introduced by Zimmer since it acquired Montreal-based ORTHOsoft in 2007 for $50 million (Canadian dollars). ORTHOsoft was founded in 1995 to develop medical software, instruments, and computerized systems.
Ivan Tornos, the company’s Chief Operating Officer, said, “as an integrated component of our ZBEdge Connected Intelligence Suite, ROSA Hip advances our vision to translate pre-, intra-and post-operative data into actionable clinical insights to inform personalized care decisions.”
