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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K253345
Device Name JARVIS Diaphyseal Stem Standard
Applicant
FH Industrie
Zi De Kernevez-6 Rue Nobel
Quimper Finistere,  FR 29000
Applicant Contact Naoual Rahimi
Correspondent
MRC Global
9085 E. Mineral Circlie
Suite 110
Centennial,  CO  80112
Correspondent Contact Christine Scifert
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS  
Date Received09/30/2025
Decision Date 10/29/2025
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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