Zimmer Biomet has received FDA 510(k) clearance for an enhanced version of its ROSA knee robotic technology, expanding its capabilities for total knee replacement procedures.
ROSA knee with OptimiZe is an upgraded robotic assistance platform used during total knee replacement surgery. It is not an implant, but a tool that helps surgeons map the knee in real time, plan where the implant should go and guide steps such as bone cuts and alignment.
The system is intended for use in robotic-assisted total knee arthroplasty procedures.
Knee replacement surgery remains one of the most common orthopedic procedures worldwide. This type of surgery is often performed to relieve pain and restore mobility in patients with advanced osteoarthritis.
The global knee replacement surgery market is projected to grow from $12.00 billion in 2025 to $16.17 billion by 2030, at a compound annual growth rate (CAGR) of 6.1%.
The clearance covers new software and tracking features that let the system collect real-time measurements, guide implant positioning and support key steps of the procedure.
The system integrates advanced features such as intelligent surgical planning and customizable surgeon profiles to help improve accuracy and reduce variability during procedures.
Surgeons can choose between functional or kinematic alignment techniques, which balance the joint based on soft tissue tension or aim to restore pre-arthritic joint lines, respectively.
The technology includes five primary enhancements:
- OptimiZe Planning, which creates surgeon-specific plans for implant positioning and knee balance
- OptimiZe Landmarking, which helps identify key points on the bone more easily
- OptimiZe Tracking, which keeps bone cuts on the planned path even if the leg moves
- OptimiZe Kinematic Alignment, which automates knee resurfacing to align with the patient’s pre-arthritic joint lines
- OptimiZe Experience, which simplifies the interface so surgeons can choose the workflow and information they want for each case.
ROSA knee with OptimiZe is compatible with the Persona knee system and integrates with ZBEdge Analytics, Zimmer Biomet’s data analytics platform. This integration will allow surgeons to review intraoperative data in real time and assess performance metrics linked to patient recovery outcomes.
The company notes that the OptimiZe Planning algorithm can reduce surgical planning time by nearly half, offering potential improvements in operating room efficiency.
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Zimmer Biomet reports that ROSA knee with OptimiZe was developed in collaboration with experienced orthopedic surgeons to address workflow challenges and improve surgical consistency.
The company plans a targeted release of the ROSA knee with OptimiZe system later in 2025, with full US commercial availability expected in the first quarter of 2026.
In the knee surgery landscape, non-surgical and regenerative strategies are also advancing, including orthobiologics — materials derived from bone, tissue or blood that aid in repair and regeneration. Keensight Capital’s recent majority investment in Isto Biologics signals continued interest in biologic materials used alongside orthopedic and spine procedures.
Digital guidance tools are evolving as well. Pixee Medical’s FDA-cleared Knee⁺ NexSight uses augmented reality (AR) navigation to deliver robotic-like precision without requiring CT scans or large capital setups, making it well-suited for outpatient centers.
Globally, the focus on training and efficiency is strengthening. In Southeast Asia, Singapore General Hospital and Johnson & Johnson MedTech have partnered to create a regional Center of Excellence for robotic-assisted knee replacement, showcasing worldwide efforts to optimize workflows and expand surgeon expertise.
Companies are also investing to make these systems more accessible beyond hospital settings. In November 2025, Distalmotion raised $150 million to accelerate US expansion of its DEXTER robotic surgery system, designed for use in ambulatory surgery centers and smaller operating rooms.
These developments are becoming a wider trend toward efficiency, mobility and data-informed decision-making in the operating room.
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