NJD

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Product code

NJD

Device name

Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer

Device class

Class 2

21 CFR

21 CFR 888.3535

Medical specialty

Orthopedic

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

5 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-09-02.

2 summaries are archived here for direct download.