FDA Product Code HSX: Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Under FDA product code HSX, non-constrained cemented femorotibial knee prostheses are cleared for unicompartmental or total knee arthroplasty.
Non-constrained designs rely on the patient's own ligaments — particularly the PCL and collateral ligaments — for joint stability, rather than on mechanical constraint from the implant. They offer more natural kinematics than constrained designs and are used in patients with intact ligamentous support.
HSX devices are Class II medical devices, regulated under 21 CFR 888.3520 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Smith & Nephew, Inc., Signature Orthopaedics Pty, Ltd. and Medacta International S.A..
List of Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer devices (product code HSX). 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 →