Description
When used with the ROSA ONE System, the ZimVie Universal Navigation System includes Universal Adapters that are intended to be used with instrumentation from Vital™ MIS Screw System, PathFinder NXT® Minimally Invasive Pedicle Screw System, and Cypher™ MIS Screw System to facilitate preparation and insertion of ZimVie screws using navigation.
When used with the Medtronic StealthStation System, the ZimVie Universal Navigation System includes Universal Adapters that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vital™ Power Instrument System), PathFinder NXT Minimally Invasive Pedicle Screw System, Cypher MIS Screw System and Polaris™ Spinal System to facilitate preparation and insertion of ZimVie screws using navigation.
As with all orthopedic surgical procedures, detailed preoperative planning is essential. Preoperative diagnostic evaluation, followed by carefully executed surgical technique is required. Postoperative care, individualized to suit the particular injury/disease requirements, is essential for optimum outcome. The surgeon must be fully aware of the risks and complications inherent to this type of surgery. Only those individuals with specialized training and experience in spinal surgery should attempt use of the instruments.
The instrument cases may be multi-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may consist of trays and holders. The instrument cases are perforated to allow steam to penetrate these various materials and components. The instrument cases will allow for sterilization of the contents to occur in a steam sterilizer utilizing a cycle that has been validated by the user for the equipment and procedures employed at the user facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap or rigid container to maintain sterility.
Indications
When used with the ROSA ONE System, the ZimVie Universal Navigation System is indicated for use during the preparation and insertion of ZimVie screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The universal adaptors are specifically designed for use with the ZimVie ROSA ONE System, which is indicated for that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The ROSA ONE Spine System is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.
Indications for compatible systems, Vital MIS Screw System, PathFinder NXT Minimally Invasive Pedicle Screw System, and the Cypher MIS Screw System can be found in their respective system IFUs.
When used with the Medtronic StealthStation System, the ZimVie Universal Navigation System is indicated for use during the preparation and insertion of ZimVie screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The universal adapters are specifically designed for use with the Medtronic StealthStation System which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a pelvis or vertebra can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for compatible systems, Vitality Spinal Fixation System (including Vital Power Instrument System), PathFinder NXT Minimally Invasive Pedicle Screw System, Cypher MIS Screw System and Polaris Spinal System, can be found in their respective system IFUs.