510(k) K211221

Porous Patella and Porous Tibia Baseplate by Smith & Nephew, Inc. — Product Code MBH

K211221 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "Porous Patella and Porous Tibia Baseplate". The FDA issued a decision of Substantially Equivalent on Oct 1, 2021. 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. Smith & Nephew, Inc. has 554 other 510(k) clearances on record.