510(k) K241944

AGILON® XO Shoulder Replacement System by Implantcast GmbH — Product Code KWT

K241944 is an FDA 510(k) premarket notification submitted by Implantcast GmbH for the device "AGILON® XO Shoulder Replacement System". The FDA issued a decision of Substantially Equivalent on March 10, 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. Implantcast GmbH has at least 10 other 510(k) clearances on record.