FDA Product Code JWJ: Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Leading manufacturers include Skeletal Dynamics, Ascension Orthopedics, Inc. and Skeletal Dynamics, Inc..
FDA 510(k) Cleared Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained Devices (Product Code JWJ)
About Product Code JWJ - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code JWJ since 1980, with 17 receiving FDA clearance (average review time: 148 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for JWJ submissions have been consistent, averaging 146 days recently vs 149 days historically.
JWJ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →