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.

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.

The CORE 2 Console is a non-sterile, 120V AC-powered, reusable device that is intended for use inside of the sterile environment during surgery. The console supplies VDC power to a range of motors for use in a variety of surgical procedures as described in its labeling. It also provides a means for irrigation through an integrated irrigation pump. The console has three motor ports, two footswitch ports, and one irrigation cassette port. CORE 2 receives identification and configuration information from connected devices including Stryker handpieces, footswitches, cutting attachments with RFID, and irrigation cassettes. The console allows further device configuration through its graphical user interface (GUI). The primary modules that comprise CORE 2 are its power supply, central processing unit, motor controller, irrigation pump controller, RFID module, liquid crystal display (LCD) screen and speaker, touchscreen interface and an Ethernet interface. The software of the CORE 2 is responsible for the integration of these modules and control of the console. The console's software receives identification and configuration information from connected devices. This information is monitored and processed based on current system configurations, and can be used to activate handpiece motors, change motor speed, and activate or deactivate irrigation, among other functions. The device modifications in scope of this premarket notification consist of updates to the CORE 2 software to allow for its use within a RISE (Reimagining Integrated Surgical Experience) ecosystem. RISE is an optional software functionality that allows for Ethernet-based communication between compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System, and Sonopet iQ consoles) and utilizes the DCM (Device Communication Module) protocol. RISE provides for an integrated OR (Operating Room) solution to healthcare facilities to simplify workflows and reduce OR clutter. In a RISE configuration, adjustment of CORE 2 power, irrigation, and handpiece settings can be made directly on a Connected OR Hub / SDC4K GUI, thereby allowing the user to input commands via a single console. RISE functionality also allows for the activation of the subject device output via a remotely connected foot pedal.