510(k) K980632

DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION by Howmedica Corp. — Product Code JWH

K980632 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION". The FDA issued a decision of Substantially Equivalent on December 11, 1998. 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. Howmedica Corp. has at least 10 other 510(k) clearances on record.