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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, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K252303
Device Name Stem Extension Line (USTAR II System)
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 Number888.3510
Classification Product Code
KRO  
Subsequent Product Codes
KWL   LPH   LWJ   LZO   OQI  
Date Received07/24/2025
Decision Date 08/22/2025
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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