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..
FDA 510(k) Cleared Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer Devices (Product Code HSX)
About Product Code HSX - Regulatory Context
510(k) Submission Activity
114 total 510(k) submissions under product code HSX since 1977, with 114 receiving FDA clearance (average review time: 111 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under HSX have taken an average of 84 days to reach a decision - down from 113 days historically, suggesting improved FDA processing for this classification.
HSX devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →