Cleared Traditional

MPO Total Knee Systems MR Labeling

K152631 · Microport Orthopedics, Inc. · Orthopedic
Mar 2016
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K152631 is an FDA 510(k) clearance for the MPO Total Knee Systems MR Labeling, a Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HRY), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on March 23, 2016, 190 days after receiving the submission on September 15, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3530.

Submission Details

510(k) Number K152631 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2015
Decision Date March 23, 2016
Days to Decision 190 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HRY — Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3530

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