CORE Shoulder System

The CORE Shoulder System is a handheld surgical instrument with computer-assisted tracking designed to assist surgeons in placing a K-wire (central guide pin) and positioning the glenoid component during primary shoulder arthroplasty procedures. It tracks the live position of surgical instruments relative to a virtual anatomical model created from preoperative CT data, allowing surgeons to visually compare planned and actual K-wire placement without tracking patient anatomy itself.

The CORE Shoulder System uses a virtual 3D model and computer-assisted instrument tracking via wireless tablet interface, whereas the predicate Glenoid IRIS uses a physical 3D model without computer-assisted instrument tracking. Both systems employ reusable stainless steel components for glenoid contact and K-wire drilling. The CORE system uses commercially available planning software (K170702) while the predicate uses proprietary software.

ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), and EMC testing. Non-clinical testing also included battery life, sensor lifecycle, patient motion risk assessment, K-wire placement accuracy in analogue glenoid models and cadaver studies, usability evaluation, cybersecurity evaluation, software validation, and sterilization validation.

Both devices share the same intended purpose of aiding K-wire positioning based on patient-specific preoperative plans using CT-derived virtual scapular models and stainless steel reusable components. Although the CORE system uses virtual tracking versus the predicate's physical model, the submission argues that scientific methods exist to evaluate whether this technological difference affects safety and effectiveness, and that performance testing (including cadaver studies comparing K-wire and implant placement accuracy) demonstrates substantial equivalence for the intended purpose.