Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories

The Q Guidance System, when used with the Spine Guidance 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 any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative 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 procedures on the pelvis and spine, including:
• Screw and Needle Placement in the spine or pelvis
• Bone resection in the spine

The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.

The CORE Q Footswitch is an accessory to the CORE 2 Console. When the pedal is actuated, it provides a signal to the console for variable speed control of the handpiece connected to the console. The footswitch is intended for use in surgical spine procedures. When used with the Stryker Spine Guidance Software, the footswitch when commanded by the console provides haptic feedback based upon user defined spatial boundaries.

The Pi Drive 2 and Pi Drive 2 Plus Motors are intended for use with the Stryker® Consolidated Operating Room Equipment (CORE™) System. The motors, when used with a compatible Elite Q Attachment and a stereotactic instrument tracker, are also indicated as an accessory to the Stryker Spine Guidance Software.

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 laminotomy / laminectomy, minimally invasive surgery (MIS) spine, and orthopedic spine.

The Q Guidance System, when used with the Spine Guidance 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 any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative 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 procedures on the pelvis and spine, including: Screw and Needle Placement in the spine or pelvis, Bone resection in the spine.

The Spine Guidance 5.1 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 5.1 Software, the Q Guidance System (computer platform), navigated accessories / instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adaptors, 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 5.1 Software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices. The CORE 2 Console has three handpiece ports, two footswitch ports, and one irrigation cassette port. The console supplies power to devices for a variety of surgical procedures as described in its indications for use. It is comprised of a power supply, central processing unit, motor controller, irrigation pump controller, RFID module, liquid crystal display (LCD) screen and speaker for output, touch screen for user input, USB port, and an Ethernet port. The CORE 2 software supports the optional high-speed drill instrument tip proximity detection feature as well as the audible and haptic feedback modalities driven by the Spine Guidance 5.1 Software. The CORE Q Footswitch connects to the CORE 2 Console and is used to control a high-speed drill. The Pi Drive 2 Motors are used with a CORE 2 Console and a compatible attachment and cutting accessory for cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures. The Elite Q Attachments serve as the interface between the Pi Drive 2 Motors and a distally attached cutting accessory. 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. This system is for professional use only within a professional healthcare environment.