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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K262293
Device Name EVOLUTION MPX™ Total Knee System
Applicant
Suzhou Microport Orthorecon Co., Ltd.
Bldg. 2 And 3, #151, Fengli St., Suzhou Industrial Park Chin
Suzhou,  CN 215000
Applicant Contact Hongxing Qiu
Correspondent
Suzhou Microport Orthorecon Co., Ltd.
Bldg. 2 And 3, #151, Fengli St., Suzhou Industrial Park Chin
Suzhou,  CN 215000
Correspondent Contact Hongxing Qiu
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
HRY  
Date Received07/07/2026
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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