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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K253948
Device Name Momentum Acetabular Cup System
Applicant
United Orthopedic Corporation
# 16. Luke 1st Rd. Luzhu Dist.
Kaohsiung City,  TW 82151
Applicant Contact Lois Ho
Correspondent
UOC USA, Inc.
15251 Alton Pkwy., Suite 100
Irvine,  CA  92618
Correspondent Contact Heather Neely
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
LPH   MEH   OQI  
Date Received12/10/2025
Decision Date 09/02/2026
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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