510(k) K122395

DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS by DePuy Orthopaedics, Inc. — Product Code HSN

K122395 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 31, 2012. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.