510(k) K031962

NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS by Implex Corp. — Product Code JWH

K031962 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS". The FDA issued a decision of Substantially Equivalent on January 8, 2004. 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. Implex Corp. has at least 10 other 510(k) clearances on record.