510(k) K222482

AGILON XO Shoulder System by Implantcast GmbH — Product Code KWT

K222482 is an FDA 510(k) premarket notification submitted by Implantcast GmbH for the device "AGILON XO Shoulder System". The FDA issued a decision of Substantially Equivalent on September 28, 2022. 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.