510(k) K260624

Arthrex Radial Head Replacement System by Arthrex, Inc. — Product Code KWI

K260624 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Radial Head Replacement System". The FDA issued a decision of Substantially Equivalent on July 30, 2026. The device falls under product code KWI (Prosthesis, Elbow, Hemi-, Radial, Polymer), a Class II device regulated under 21 CFR 888.3170. Arthrex, Inc. has at least 10 other 510(k) clearances on record.