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Spine Guidance 5.4 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)

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.

Maestro Air Motor:

The Stryker Consolidated Operating Room Equipment (CORE™) Maestro Air Pneumatic System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

The Maestro Air Motor, when used with a compatible Elite Q Attachment and a stereotactic instrument tracker, is also indicated as an accessory to the Stryker Spine Guidance Software.

The Spine Guidance 5.4 System is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery.

The system is comprised of the Spine Guidance 5.4 Software, the Q Guidance System (computer platform), Mako Spine System, navigated accessories / instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adapters, patient / instrument trackers, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies.

The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 5.4 Software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices.

The Spine Guidance 5.4 Software includes all the existing features from the Spine Guidance 5.3 Software described in K252871. Updates to the software include the integration of the Q Drill Tracker as a new system component, ability to navigate the Maestro Air Motor, integration of additional burs, and now allows the NavLock Adapter to be used with two additional trackers.

The Maestro Air Motor is intended to be used with a compatible attachment and cutting accessory for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone and bone cement in a variety of surgical procedures. The motor is usable in placement or cutting of screws, metals, wires, pins, and other fixation devices. The motor can also be navigated when performing computer assisted surgery using Spine Guidance 5.4 Software.

The Elite Q Attachments serve as the interface between a compatible motor and a distally attached cutting accessory. The Elite Q Attachments provide a location for mounting a stereotactic instrument tracker and support navigation of a high-speed drill as well as the system's instrument tip proximity detection feature.

The Elite Cutting Accessories are used for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement 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 navigation of a high-speed drill as well as the system's instrument tip proximity detection feature.

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