Product code NJD

Device name

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

Medical specialty

Orthopedic

Device class

2

Regulation number

888.3535

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset