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 Precision AI Pty, Ltd..
FDA 510(k) Cleared Shoulder Arthroplasty Implantation System Devices (Product Code QHE)
About Product Code QHE - Regulatory Context
510(k) Submission Activity
24 total 510(k) submissions under product code QHE since 2019, with 24 receiving FDA clearance (average review time: 120 days).
Submission volume has remained relatively stable over the observed period, with 9 submissions in the last 24 months.
FDA Review Time
Recent submissions under QHE have taken an average of 132 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
QHE devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →