510(k) K930595

AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY by Orthomet, Inc. — Product Code JWH

K930595 is an FDA 510(k) premarket notification submitted by Orthomet, Inc. for the device "AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY". The FDA issued a decision of SN on October 22, 1993. 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. Orthomet, Inc. has at least 10 other 510(k) clearances on record.