FDA Product Code QHE: Shoulder Arthroplasty Implantation System

Precise component placement is critical to the outcomes of shoulder replacement surgery. FDA product code QHE covers shoulder arthroplasty implantation systems — instrumented systems designed to assist surgeons in accurately preparing the bone and seating the prosthetic components.

These systems include patient-specific guides, navigation tools, and mechanical jigs that improve the accuracy of glenoid and humeral preparation, potentially reducing the risk of implant malposition and early failure.

QHE devices are Class II medical devices, regulated under 21 CFR 888.3660 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Materialise NV, Orthosoft Inc. (d/b/a) Zimmer CAS and Precision AI Pty, Ltd..