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, Arthrex, Inc. and Lima Corporate S.P.A..
List of Shoulder Arthroplasty Implantation System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Shoulder Arthroplasty Implantation System devices (product code QHE). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →