Cleared Traditional

Smith and Nephew Legion Hinge Knee System

K151118 · Smith & Nephew · Orthopedic
Jul 2015
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K151118 is an FDA 510(k) clearance for the Smith and Nephew Legion Hinge Knee System, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Smith & Nephew (Memphis, US). The FDA issued a Cleared decision on July 28, 2015, 92 days after receiving the submission on April 27, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K151118 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2015
Decision Date July 28, 2015
Days to Decision 92 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3510

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