Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece

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.

Q Pedicle Instruments (QPI)
Stryker Spine Q Pedicle Instruments are intended to be used as accessories to the Stryker Spine Guidance System to facilitate placement of Stryker Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, Stryker Spine Q Pedicle Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with a Q Navigation Adaptor and associated trackers manually or under power with a Stryker Rotary Handpiece to facilitate pedicle preparation and placement of Stryker Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients in accordance with the indications and contraindications of the associated Stryker Spine Implant System.

Consolidated Operating Room Equipment (CORE) 2 Console
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 orthopedic, 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.

Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece
The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece is used with the Consolidated Operating Room Equipment (CORE™) System. When used with a variety of Stryker-approved attachments, the handpiece is intended for orthopedic surgical procedures involving drilling, reaming, driving wire or pins, cutting bone and hard tissue. The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece, when used in conjunction with Stryker Spine Guidance Software, is intended to be used to facilitate preparation and placement of screws of Stryker Spine implant systems in adult and pediatric (adolescent) patients.

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.

The Spine Guidance 5.0 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 5.0 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 5.0 software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices. The following new instrumentation can be used with the system: The Q Pedicle Instruments are intended to be used to facilitate pedicle preparation and screw placement of Stryker Spine implant systems. 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 contains an optional depth-stop feature driven by Spine Guidance 5 Software. The ES 6 Heavy Duty Dual Trigger Rotary Handpiece is used in drilling, reaming and decorticating of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement of screws, wires, pins, and other fixation devices. This handpiece supports the depth-stop feature. This system is for professional use only within a professional healthcare environment.