Cleared Traditional

JOURNEY II Unicompartmental Knee System (JOURNEY II UK)

K242711 · Smith & Nephew, Inc. · Orthopedic
Oct 2024
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K242711 is an FDA 510(k) clearance for the JOURNEY II Unicompartmental Knee System (JOURNEY II UK), a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on October 30, 2024, 51 days after receiving the submission on September 9, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number K242711 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2024
Decision Date October 30, 2024
Days to Decision 51 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3520

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