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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K243656
Device Name U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella
Applicant
United Orthopedic Corporation
No 57, Park Ave. 2, Science Park
Hsinchu City,  TW 30075
Applicant Contact Lois Ho
Correspondent
NJK & Associates, Inc.
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact Natalie J Kennel
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   KRO  
Date Received11/26/2024
Decision Date 07/31/2025
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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