FDA Product Code NJD: Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Intended To Replace Part Of A Knee Joint In Order To Relieve Pain And Restore Knee Function, For Indications Such As Uni-compartmental Osteoarthritis; Inflammatory Arthritis; Traumatic Arthritis; Varus, Valgus Or Flexion Deformities; And Revision Surgery.
Leading manufacturers include Ignite Orthomotion and Smith & Nephew, Inc..
FDA 510(k) Cleared Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer Devices (Product Code NJD)
About Product Code NJD - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code NJD since 2014, with 5 receiving FDA clearance (average review time: 146 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NJD have taken an average of 101 days to reach a decision - down from 177 days historically, suggesting improved FDA processing for this classification.
NJD devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →