510(k) K024161

NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS by Implex Corp. — Product Code JWH

K024161 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS". The FDA issued a decision of Substantially Equivalent on January 15, 2003. 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.