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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 K253159
Device Name Prophecy Incompass Surgical Planning System
Applicant
Wright Medical Technology, Inc. (Stryker)
1023 Cherry Rd.
Memphis,  TN  38117
Applicant Contact Jonathan DiMotta
Correspondent
Wright Medical Technology, Inc. (Stryker)
1023 Cherry Rd.
Memphis,  TN  38117
Correspondent Contact Jonathan DiMotta
Regulation Number888.3110
Classification Product Code
HSN  
Subsequent Product Codes
OYK   PBF  
Date Received09/26/2025
Decision Date 06/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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