Zimmer Biomet has received 510(k) clearance from the US Food and Drug Administration (FDA) for ROSA Knee with OptimiZe technology.
It is an updated version of the ROSA Knee system that helps surgeons deliver personalised and consistent outcomes during robotic-assisted total knee replacement procedures.
ROSA Knee with OptimiZe introduces customised intelligent surgical planning and new tools for positioning, tracking, and alignment, to reduce user variability and improve accuracy.
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The system offers a simplified user interface, enabling surgeons to select the information and workflow options relevant to each case.
ROSA Knee with OptimiZe is compatible with the Persona Knee System and is helpful for surgeons who use both functional and kinematic alignment.
Surgeons using functional alignment can access surgeon profiles that generate plans customised to both patient anatomy and surgeon preference.
For those preferring kinematic alignment, ROSA Knee with OptimiZe provides an automated alignment feature intended to restore the knee’s pre-arthritic position.
Zimmer Biomet senior vice-president and chief information and technology officer Shaun Braun said: “As a leader in advancing innovation in orthopaedic robotics, we are committed to improving and enhancing our robotic technologies to better meet the needs of surgeons and improve efficiency in the OR, with the ultimate goal of delivering better outcomes for patients.
“ROSA Knee with OptimiZe was designed in partnership with our seasoned team of ROSA surgeons to make robotic-assisted knee replacement surgery more personalised, accurate and efficient for surgeons.
“With our proprietary algorithm, OptimiZe Planning, surgeons can create customised profiles that generate personalised surgical plans, which can reduce planning time by an average of 46%.”
ROSA Knee with OptimiZe brings five key enhancements, including automated kinematic alignment plan, customised planning to guide implant positioning, interface enabling workflow personalisation, motion-sensitive tracking, and a simplified landmarking tool.
The system also integrates with ZBEdge Analytics to support data-driven decisions and performance assessment during surgery.
Zimmer Biomet plans a targeted release of ROSA Knee with OptimiZe later this year, with broader commercial US availability anticipated in the first quarter of 2026.
In March 2025, the FDA granted 510(k) clearance to Zimmer Biomet’s new revision knee implant component, the Persona Revision SoluTion Femur.
