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The ROSA Knee System, for use with the ROSA® RECON platform, is indicated as a stereotaxic instrumentation system for total knee replacement surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.

The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively, and based on a surgical plan optionally determined pre-operatively using compatible X-ray based surgical planning tools. It includes a robotic arm, an optical tracking system and accessories, software system, surgical instruments and accessories.

The ROSA Knee System is designed for use on skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the ROSA Knee System.

The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: NexGen® CR, NexGen CR-Flex, NexGen CR-Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS, Persona® PPS® CR, Persona® PPS® PS, Persona SoluTion PPS, Persona IQ® The Smart Knee™, Vanguard® CR, and Vanguard PS.

The ROSA® Knee System for use with the ROSA® RECON platform is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections as well as assessing the state of the soft tissues to facilitate implant positioning intra-operatively.

The ROSA® Knee System uses a Non-Device Medical Device Data System (MDDS) called the Zimmer Biomet Portal which manages the creation and tracking of surgical cases. The cases reside on the portal until they are uploaded to the ROSA® RECON Platform before surgeries.

If the case is image-based, a 3D virtual bone model is generated pre-operatively by the PSI system (X-PSI Knee System K171269) to create a 3D model of the patient's femur/tibia and allows the preparation of a pre-operative surgical plan as well as visualization of planned cuts. The pre-operative plan is then matched to the landmarks taken intra-operatively on the patient's bony anatomy. An imageless option is also available where landmarks taken intra-operatively on the patient's bony anatomy are used to create the surgical plan. Accuracy of resections, knee state evaluation, and soft tissue assessment are the same between image-based and imageless options as they are always based on intra-operative landmarks.

The intraoperative workflow and surgical concepts implemented in the ROSA Knee System remain close to the conventional TKA workflow. As such, at the time of the surgery, the system mainly assists the surgeon in (1) Determining reference alignment axes in relation to anatomical landmarks, (2) planning the orthopedic implants location based on these reference alignment axes and orthopedic implant geometry (planning optionally based on a pre-operative plan using pre-operative imaging), and (3) precisely positioning the cut guide relative to the planned orthopedic implant location by using a robotic arm.

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