Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories

The Q Guidance System, when used with the Spine Guidance 5 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified. The system assists in the positioning of instruments for surgical procedures on the spine and pelvis, including:
- Screw and Needle Placement in the spine or pelvis
- Bone resection in the spine
- Interbody device placement in the lumbar spine (adults only)

The Q Guidance System, when used with the Spine Guidance 5 Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for orthopedic and neurological spine procedures in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative stereotaxic guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified. The system assists in the positioning of instruments for surgical procedures on the spine and pelvis, including: Screw and Needle Placement in the spine or pelvis, Bone resection in the spine, Interbody device placement in the lumbar spine (adults only).

The Spine Guidance 5.3 Software includes all the existing features from the Spine Guidance 5.2 Software described in K241517 as well as new features and functionality for the new software indication for interbody device (cage) placement. New features and functionality in the Spine Guidance 5.3 Software include the following: New user settings where the user can select the cage family and size to be used as default in Navigation; New user setting to visualize instruments and implants as 3D models within the Navigation views; Integration and visualization of the following VB Spine Cage implant families: Cascadia AN, Tritanium PL, Cascadia Lateral; Supports and visualizes navigation enabled instruments for interbody placement workflow such as inserters, dilators, disc prep instruments, and interbody trials, as well as system components such as calibration devices and adaptors. Once the instruments have been calibrated, the software can identify the instrument tip and axis and display it on the screen during Navigation. When the user calibrates the interbody inserter, the cage inserter family is automatically identified by the software. The family is determined by the specific and unique length of the inserter and calibration tip.