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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 K173875
Device Name GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
Applicant
Stelkast, Inc.
200 Hidden Valley Rd.
Mcmurray,  PA  15317
Applicant Contact Dave Stumpo
Correspondent
Musculoskeletal Clinical Regulatory Advisors
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Hollace Rhodes
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received12/21/2017
Decision Date 01/19/2018
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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