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The Tracker / September 2026 / K262293

510(k) cleared

EVOLUTION MPX Total Knee System

Suzhou Microport Orthorecon Co., Ltd. · Sep 10, 2026 · K262293

FDA cleared the EVOLUTION MPX Total Knee System from Suzhou Microport Orthorecon Co., Ltd. on Sep 10, 2026 under K262293, a traditional 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 7, 2026. The decision came 65 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Suzhou Microport Orthorecon Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262293?

K262293 is the FDA 510(k) for EVOLUTION MPX Total Knee System, submitted by Suzhou Microport Orthorecon Co., Ltd.. FDA's decision date was Sep 10, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the EVOLUTION MPX Total Knee System?

Suzhou Microport Orthorecon Co., Ltd., based in Suzhou, is the applicant of record for K262293.

How long did the K262293 review take?

FDA received the submission on Jul 7, 2026 and issued its decision on Sep 10, 2026, 65 days later.

← All decisions in September 2026