ROSA Surgical Platform (Zimmer Biomet)
Robotic surgical assistant for orthopedic and neurosurgical applications, including knee replacement, hip replacement, and spinal procedures.
What This Technology Is
ROSA (Robotic Surgical Assistant) is a robotic platform developed by Zimmer Biomet for orthopedic and neurosurgical applications. The system assists surgeons with precision positioning of instruments and implants in knee replacement, hip replacement, and spinal procedures.
Originally developed by Medtech SA (acquired by Zimmer Biomet in 2016), ROSA platforms include:
- ROSA Knee: For total and partial knee replacement
- ROSA Hip: For total hip arthroplasty
- ROSA One Spine: For spinal fusion and other spine procedures
- ROSA One Brain: For neurosurgical applications
For orthopedic applications, ROSA uses preoperative imaging (X-ray-based for some applications, CT for others) combined with intraoperative data to create surgical plans. The robotic arm then assists with bone preparation and implant positioning.
Where It Is Deployed
ROSA systems are installed in hospitals and surgical centers in North America, Europe, and other markets where Zimmer Biomet has regulatory clearance. The platform represents Zimmer Biomet's primary robotic surgery offering, positioning against Stryker's Mako system in orthopedics and against other platforms in spine surgery.
Applications include:
- Total knee arthroplasty
- Partial knee arthroplasty
- Total hip arthroplasty
- Pedicle screw placement in spinal fusion
- Neurosurgical biopsy and electrode placement
Known and Documented Failure Modes
ROSA systems share failure categories with other orthopedic and surgical robots, with some platform-specific considerations:
Registration and planning
- Image-to-patient registration errors
- X-ray-based planning limitations compared to CT-based systems
- Soft tissue movement affecting bone landmark identification
Mechanical and system
- Arm positioning errors
- Instrument tracking failures
- System software errors
- Calibration drift over procedure duration
Clinical events documented in MAUDE reports
- Bone cuts outside planned parameters
- System malfunctions requiring conversion to manual technique
- Extended operative times
- Implant positioning deviations
Spine-specific considerations
- Pedicle screw misplacement despite robotic guidance
- Spinal cord or nerve root proximity risks
- Fluoroscopic radiation exposure during registration
Oversight and Regulatory Context
ROSA platforms have FDA 510(k) clearance in the United States and CE Mark certification in Europe. Regulatory pathways mirror those of comparable robotic systems.
Notable considerations:
- Multiple application platforms: Different ROSA systems have different intended uses, requiring clinicians and patients to understand which system is relevant
- Imaging requirements vary: Some ROSA applications use X-ray-based planning while others require CT, affecting preoperative workflow and radiation exposure
- Market competition: Zimmer Biomet competes with Stryker (Mako), Smith+Nephew, and others in orthopedic robotics
Why This Matters
The expansion of robotic options in orthopedic surgery may benefit patients through innovation and competition, but also creates complexity. Different systems use different planning approaches, different imaging modalities, and different intraoperative techniques.
For patients, the brand of robot matters less than:
- Surgeon experience with the specific system
- Institutional outcomes data
- Whether robotic assistance has demonstrated benefit for their procedure
- Contingency plans if the system fails during surgery
External Resources
- Zimmer Biomet ROSA — Manufacturer information (commercial source)
- FDA MAUDE Database
Related Coverage
Report an Incident
If you have direct knowledge of a ROSA system malfunction, unexpected outcome, or safety concern, you can submit documentation to Safety Ledger.