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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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K261032
Device Name NovoKnee (SteriKnee)
Applicant
NovoSource
1000 Hampton Center Suite A
Morgantown,  WV  26505
Applicant Contact Doug Hawkins
Correspondent
NovoSource
1000 Hampton Center Suite A
Morgantown,  WV  26505
Correspondent Contact Doug Hawkins
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/30/2026
Decision Date 04/27/2026
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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