510(k) K131398

NOVOKNEE TOTAL KNEE SYSTEM by Novosource, Inc. — Product Code JWH

K131398 is an FDA 510(k) premarket notification submitted by Novosource, Inc. for the device "NOVOKNEE TOTAL KNEE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 16, 2013. 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. Novosource, Inc. has at least 4 other 510(k) clearances on record.