510(k) K162222

GENflex2 Total Knee System by Stelkast, Inc. — Product Code JWH

K162222 is an FDA 510(k) premarket notification submitted by Stelkast, Inc. for the device "GENflex2 Total Knee System". The FDA issued a decision of Substantially Equivalent on September 7, 2016. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Stelkast, Inc. has at least 10 other 510(k) clearances on record.