510(k) K031462

THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS by Implex Corp. — Product Code MBH

K031462 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS". The FDA issued a decision of Substantially Equivalent on August 6, 2003. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Implex Corp. has at least 10 other 510(k) clearances on record.