510(k) K231253

Overture Orthopaedics Patellofemoral System by Overture Resurfacing, Inc. — Product Code KRR

K231253 is an FDA 510(k) premarket notification submitted by Overture Resurfacing, Inc. for the device "Overture Orthopaedics Patellofemoral System". The FDA issued a decision of Substantially Equivalent on July 7, 2023. The device falls under product code KRR (Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3540. Overture Resurfacing, Inc. has at least 1 other 510(k) clearance on record.