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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, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
510(k) Number K251975
Device Name Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
Applicant
Ignite Orthomotion
700 Park Ave.
Suite F
Winona Lake,  IN  46590
Applicant Contact Russell Parrott
Correspondent
Ignite Orthomotion
700 Park Ave.
Suite F
Winona Lake,  IN  46590
Correspondent Contact Russell Parrott
Regulation Number888.3535
Classification Product Code
NJD  
Subsequent Product Code
HSX  
Date Received06/26/2025
Decision Date 09/02/2025
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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