510(k) K242746

OvertureTi Knee Resurfacing SystemTM by Overture Orthopaedics — Product Code HSX

K242746 is an FDA 510(k) premarket notification submitted by Overture Orthopaedics for the device "OvertureTi Knee Resurfacing SystemTM". The FDA issued a decision of Substantially Equivalent on October 7, 2024. The device falls under product code HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3520.