510(k) K120990

NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL by Zimmer Trabecular Metal Technology — Product Code MBH

K120990 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular Metal Technology for the device "NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL CONES PROVISIONALS TO NEXGEN LCCK TRABECULAR METAL (TM) COUPLED TIBIAL". The FDA issued a decision of Substantially Equivalent on June 29, 2012. 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 Metal Technology has at least 10 other 510(k) clearances on record.