Product code NJD— Orthopedic

ACHIEVE Partial Knee System

Classification name: Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Device class: Class 2
Regulation: 21 CFR 888.3535
Advisory panel: Orthopedic
Total cleared: 5
First cleared: 2014-07-08
Most recent: 2025-09-02

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.”
— U.S. Food and Drug Administration, device classification record for product code NJD under 21 CFR 888.3535, via openFDA

Market context for product code NJD

FDA has cleared 5 devices under product code NJD between 2014 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20251 clearance
20241 clearance
20221 clearance
20191 clearance
20141 clearance

Top applicants under product code NJD

Ignite Orthomotion2 clearances
Smith+Nephew, Inc.1 clearance
Mako Surgical Corp.1 clearance
Engage Uni, LLC1 clearance

Recent clearances under product code NJD

K251975 — Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion·2025-09-02
K242307 — ACHIEVE Partial Knee SystemIgnite Orthomotion·2024-12-16
K222653 — JOURNEY II UK and ENGAGE Cementless Partial Knee SystemSmith+Nephew, Inc.·2022-10-28
K190439 — Engage Partial Knee SystemEngage Uni, LLC·2019-11-21
K133811 — RESTORIS POROUS PARTIAL KNEE SYSTEMMako Surgical Corp.·2014-07-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.