510(k) K053340

TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS by Zimmer Trabecular — Product Code MBH

K053340 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular for the device "TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS". The FDA issued a decision of Substantially Equivalent on February 27, 2006. 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. Zimmer Trabecular has at least 9 other 510(k) clearances on record.