510(k) K223252

TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas by Exactech, Inc. — Product Code JWH

K223252 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas". The FDA issued a decision of Substantially Equivalent on July 17, 2023. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Exactech, Inc. has at least 10 other 510(k) clearances on record.