Cleared Traditional

EVOLUTION Revision CCK System

K171389 · Microport Orthopedics, Inc. · Orthopedic
Aug 2017
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K171389 is an FDA 510(k) clearance for the EVOLUTION Revision CCK System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on August 8, 2017, 89 days after receiving the submission on May 11, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number K171389 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 2017
Decision Date August 08, 2017
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3560

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