Cleared Traditional

EVOLUTION Stemmed CS Femur

K182125 · Microport Orthopedics, Inc. · Orthopedic
Dec 2018
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K182125 is an FDA 510(k) clearance for the EVOLUTION Stemmed CS Femur, 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 December 6, 2018, 122 days after receiving the submission on August 6, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number K182125 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2018
Decision Date December 06, 2018
Days to Decision 122 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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