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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K250037
Device Name Incompass Total Ankle System
Applicant
Wright Medical Technology, Inc. (Stryker)
1023 Cherry Rd.
Memphis,  TN  38117
Applicant Contact Antonio Ayala
Correspondent
Wright Medical Technology, Inc. (Stryker)
1023 Cherry Rd.
Memphis,  TN  38117
Correspondent Contact Antonio Ayala
Regulation Number888.3110
Classification Product Code
HSN  
Date Received01/08/2025
Decision Date 06/20/2025
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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