510(k) K202194

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology by Depuy Ireland UC — Product Code MBH

K202194 is an FDA 510(k) premarket notification submitted by Depuy Ireland UC for the device "ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology". The FDA issued a decision of Substantially Equivalent on Nov 25, 2020. 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. Depuy Ireland UC has 49 other 510(k) clearances on record.