CORIOGRAPH Pre-Op Planning and Modeling Services

CORIOGRAPH Pre-Op Planning and Modeling Services is a software system that generates preoperative surgical plans for orthopedic procedures (knee, hip, and shoulder replacement) based on patient imaging scans. The software analyzes patient anatomy and surgeon preferences to recommend implant placement, and includes modeler modules that allow surgeons to simulate and refine the plan using biomechanical analyses like range-of-motion and activities-of-daily-living simulations.

The subject device introduces two new medical software modules: CORIOGRAPH Shoulder Pre-Op Plan (v1.0) and CORIOGRAPH Shoulder Modeler (v1.0). These modules use the same software architecture, planning processes, and kinematic modeling approaches as the existing hip and knee modules in the primary predicate device. The shoulder modeler provides impingement-free range-of-motion and activities-of-daily-living simulation capabilities equivalent to the hip modeler.

IEC 62304 Medical device software - Software life cycle processes; IEC 62366 Application of Usability Engineering to Medical Devices; FDA Guidance for Content of Premarket Submissions for Device Software Functions.

The shoulder planning and modeling modules use identical software development, verification, and validation methodologies as the predicate device's hip modules. The kinematic models and simulation tools are clinically relevant and were demonstrated to be safe and effective through summative usability testing with representative users. Since the shoulder procedures (aTSA and rTSA) are performed with the same Smith+Nephew implant systems already supported, and the new modules share the same technological architecture and planning processes as existing predicate modules, the device is substantially equivalent in intended use, functionality, and safety/effectiveness profile.