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): 5

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.

Number	Decision date	Applicant	Device name
K251975	2025-09-02	Ignite Orthomotion	Achieve Partial Knee System - Porous Coated CoCrMo F summary
K242307	2024-12-16	Ignite Orthomotion	ACHIEVE Partial Knee System summary

Official FDA classification page: NJD

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