510(k) K162256

Klassic Femur, Porous, Klassic Tibial Baseplate, Porous by Total Joint Orthopedics, Inc. — Product Code MBH

K162256 is an FDA 510(k) premarket notification submitted by Total Joint Orthopedics, Inc. for the device "Klassic Femur, Porous, Klassic Tibial Baseplate, Porous". The FDA issued a decision of Substantially Equivalent on October 27, 2016. 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. Total Joint Orthopedics, Inc. has at least 10 other 510(k) clearances on record.