ROSA® Knee System
Orthosoft Inc. (d/b/a) Zimmer CASThe ROSA Knee System is a robotic-assisted surgical device used during total knee replacement surgeries. It helps surgeons precisely place knee implants by using software to define spatial boundaries relative to anatomical landmarks and utilizing a robotic arm to guide bone resections and implant positioning. This system can integrate pre-operative imaging such as X-rays or MRI to plan surgeries more accurately and improve surgical outcomes.
Intended Use
The ROSA Knee System, for use with the ROSA RECON platform, is a stereotaxic instrumentation system for total knee replacement (TKA) surgery assisting surgeons by providing software-defined spatial boundaries for orientation and reference to anatomical structures for accurate placement of knee implants.
Technology
The system includes a robotic arm, optical tracking system, software, surgical instruments and accessories. It operates by defining anatomical landmarks intraoperatively, optionally using preoperative imaging and surgical planning, then guiding precise cut guide positioning with robotic arm assistance.
Performance
The performance data previously established for the predicate ROSA Knee System remains applicable and unchanged for this updated device. No new safety or effectiveness concerns were raised.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/20/2024
28 days - 2
FDA Approval
10/18/2024
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