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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 K252725
Device Name Stem Extension Line (U2 Total Knee System—PSA Type)
Applicant
United Orthopedic Corporation
No 16. Luke 1 St. Rd., Luzhu Dist.
Kaohsiung,  TW 85121
Applicant Contact Lois Ho
Correspondent
United Orthopedic Corporation
No 16. Luke 1 St. Rd., Luzhu Dist.
Kaohsiung,  TW 85121
Correspondent Contact Lois Ho
Regulation Number888.3560
Classification Product Code
JWH  
Date Received08/28/2025
Decision Date 09/25/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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