FDA Product Code JWH: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Total knee replacement is one of the most common orthopedic procedures in the United States. FDA product code JWH covers semi-constrained patellofemorotibial knee prostheses — implants that replace the articular surfaces of the femur, tibia, and patella to restore pain-free mobility.
These systems are designed to replicate the biomechanics of the natural knee while providing long-term stability. They are used in patients with advanced osteoarthritis, rheumatoid arthritis, or post-traumatic joint damage.
JWH devices are Class II medical devices, regulated under 21 CFR 888.3560 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Conformis, Inc., Smith & Nephew, Inc. and Maxx Orthopedics, Inc..
FDA 510(k) Cleared Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer Devices (Product Code JWH)
About Product Code JWH - Regulatory Context
510(k) Submission Activity
911 total 510(k) submissions under product code JWH since 1976, with 911 receiving FDA clearance (average review time: 135 days).
Submission volume has remained relatively stable over the observed period, with 37 submissions in the last 24 months.
FDA Review Time
Recent submissions under JWH have taken an average of 80 days to reach a decision - down from 138 days historically, suggesting improved FDA processing for this classification.
JWH devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →