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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/Polymer, Porous Uncemented
510(k) Number K242045
Device Name Initia T3 Acetabular Hemispherical Shell System
Applicant
Kyocera Medical Technologies, Inc.
1200 California St.
Suite 210
Redlands,  CA  92374
Applicant Contact Sumihiko Maeno
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Hannah Taggart
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
LZO  
Date Received07/12/2024
Decision Date 04/10/2025
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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