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Spine Guidance 5.3 Software Indications for Use:
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)

Q Interbody Instruments Indications for Use:
VB Spine Q Interbody Instruments are intended to be used as accessories to the Stryker Spine Guidance System to facilitate placement of VB Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, VB Spine Q Interbody Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with associated trackers and adaptors to facilitate preparation and placement of VB Spine interbody implants in accordance with the indications and contraindications of the associated VB Spine Implant System and/or Stryker Spine Guidance System.

Elite Q Attachments and Cutting Accessories:
The Elite Q Attachments and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE™) 2 Console and the Pi Drive 2 Motor or the Pi Drive 2 Plus Motor.

The Elite Q Attachments, when used with a compatible motor and a stereotactic instrument tracker, are also indicated as an accessory to the Stryker Spine Guidance Software.

Specific applications include but are not limited to minimally invasive spine (MIS) Spine applications, such as foraminotomy, facetectomy; orthopedic and neurological spine applications, such as corpectomy, pedicle subtraction osteotomy; and laminotomy / laminectomy.

5.1 Spine Guidance 5.3 Software

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.

5.2 Q Interbody Instruments

The Q Interbody Instruments in scope of this traditional 510(k) include Q Dilators, Q Disc Prep Instruments such as Q Disc Cutters, Q Box Chisels, etc. as well as new system components including the Q Long Adaptor and Q Long Adaptor Calibration Tool. The Q Interbody Instruments are intended to be used to facilitate preparation and placement of VB Spine interbody implants.

5.3 Elite Q Attachments

The Elite Q Attachments serve as the interface between the Pi Drive 2 Motors and a distally attached cutting accessory. The Elite Q Attachments provide a location for mounting a stereotactic instrument tracker and support the high-speed drill instrument tip proximity detection feature of the Spine Guidance Software.

5.4 Elite Cutting Accessories

The Elite Cutting Accessories are used for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement, and teeth in a variety of surgical procedures. The cutting accessories can also be used in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The cutting accessories support the high-speed drill instrument tip proximity detection feature of the Spine Guidance Software.

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