Cleared Traditional

JOURNEY II UK? and ENGAGE? Cementless Partial Knee System

K222653 · Smith & Nephew, Inc. · Orthopedic

Oct 2022

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K222653 is an FDA 510(k) clearance for the JOURNEY II UK? and ENGAGE? Cementless Partial Knee System, a Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer (Class II — Special Controls, product code NJD), submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on October 28, 2022, 57 days after receiving the submission on September 1, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3535.

Submission Details

510(k) Number	K222653 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 01, 2022
Decision Date	October 28, 2022
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NJD — Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3535
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.