Consolidated Operating Room Equipment (CORE) 2 Console

The CORE 2 Console is a non-sterile, AC-powered surgical console that supplies 40V DC power to various surgical handpieces and provides integrated irrigation for procedures including orthopedic, dental, ENT, neuro, spine, and endoscopic applications. It also serves as an accessory to Stryker Spine Guidance Software for stereotactic spine surgery.

The subject device is identical to the predicate in dimensions, weight, energy source, internal hardware components, user interface, irrigation system, and connectivity. The only differences are a software update enabling RISE ecosystem integration (Ethernet-based communication with other OR devices) and additional mapping indicators for handpiece and footswitch ports.

Software and wireless technology testing per FDA guidance documents and recognized standards; EMC and Electrical Safety testing per FDA recognized standards; bench testing and simulated use testing per internal protocols; human factors testing per FDA guidance documents and recognized standards.

The subject device has identical intended use, indications, operating principles, energy source, and functional outputs as the predicate. The software modifications only add optional connectivity features that do not change the core safety or effectiveness of the device's surgical functions. Performance testing confirmed no new safety or effectiveness issues, and the device performs the same functional tasks as the predicate.