510(k) K240393

Exactech® TRULIANT® Knee System by Exactech, Inc. — Product Code MBH

K240393 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "Exactech® TRULIANT® Knee System". The FDA issued a decision of Substantially Equivalent on October 3, 2024. 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. Exactech, Inc. has at least 10 other 510(k) clearances on record.