Cleared Traditional

K240043 - EVOLUTION® Hinge Knee System (FDA 510(k) Clearance)

Also includes:

GUARDIAN™ limb Salvage System DCW Modular Distal Femoral System REPIPHYSIS™ Limb Salvage System EVOLUTION® MP Total Knee System EVOLUTION® MP Total Knee System EVOLUTION® MP Adaptive CS Insert EVOLUTION® MP Adaptive PS Tibial Insert EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts EVOLUTION® Revision CCK System ADVANCE® Double High Insert ADVANCE® A-CLASS® Tibial Insert ADVANCE® Knee System ADVANCE® Ultra-Congruent Tibial Inse

K240043 · Microport Orthopedics, Inc. · Orthopedic device

Apr 2024

Decision

87d

Days

Class 2

Risk

K240043 is an FDA 510(k) clearance for the EVOLUTION® Hinge Knee System. This device is classified as 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 April 1, 2024, 87 days after receiving the submission on January 5, 2024.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3510.

Submission Details

510(k) Number	K240043 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 05, 2024
Decision Date	April 01, 2024
Days to Decision	87 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