NPJ

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product code: NPJ
Device name: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
21 CFR: 21 CFR 888.3560
Medical specialty: Orthopedic
Marketing pathway: 510(K)
Flag: Implant
510(k) clearances (last 3 years): 12

FDA classification definition

The device is intended to replace the medial condyle and the patellofemoral compartment of the distal femur with a single device. The device is meant to be used with a uni-compartmental tibial base and insert and a resurfacing patella. The device is intended to be used with bone cement.

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

Official FDA classification page: NPJ

Classification and pathway per current FDA publications. Data from openFDA (CC0).