510(k) K250713

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants by Exactech, Inc. — Product Code KWT

K250713 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants". The FDA issued a decision of Substantially Equivalent on December 1, 2025. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Exactech, Inc. has at least 10 other 510(k) clearances on record.