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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K251052
Device Name Trivicta® Hip Stem
Applicant
Ortho Development Corp.
12187 S. Business Park Dr.
Draper,  UT  84020
Applicant Contact Drew Weaver
Correspondent
Ortho Development Corp.
12187 S. Business Park Dr.
Draper,  UT  84020
Correspondent Contact Drew Weaver
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Codes
KWL   LPH   LZO  
Date Received04/03/2025
Decision Date 05/22/2025
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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