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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 K263065
Device Name MicroPort Total Knee System
Applicant
Suzhou Microport Orthorecon Co., Ltd.
Bldg. 2 And 3, #151, Fengli St., Suzhou Industrial Park Chin
Pilot Free Trade Zone Suzhou District Park China (Jiangsu)
Suzhou,  CN 215000
Applicant Contact Hongxing Qiu
Correspondent
Suzhou Microport Orthorecon Co., Ltd.
Bldg. 2 And 3, #151, Fengli St., Suzhou Industrial Park Chin
Pilot Free Trade Zone Suzhou District Park China (Jiangsu)
Suzhou,  CN 215000
Correspondent Contact Hongxing Qiu
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
HRY  
Date Received09/01/2026
Decision Date 10/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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