Cleared Traditional

EVOLUTION? Hinge Knee System

K230563 · Microport Orthopedics, Inc. · Orthopedic
Sep 2023
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K230563 is an FDA 510(k) clearance for the EVOLUTION? Hinge Knee System, a Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (Class II — Special Controls, product code KRO), submitted by Microport Orthopedics, Inc. (Arlington, US). The FDA issued a Cleared decision on September 27, 2023, 210 days after receiving the submission on March 1, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number K230563 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2023
Decision Date September 27, 2023
Days to Decision 210 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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