510(k) K230513

Arthrex Univers Apex OptiFit Humeral Stem by Arthrex, Inc. — Product Code KWS

K230513 is an FDA 510(k) premarket notification submitted by Arthrex, Inc. for the device "Arthrex Univers Apex OptiFit Humeral Stem". The FDA issued a decision of Substantially Equivalent on September 26, 2023. The device falls under product code KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3660. Arthrex, Inc. has at least 10 other 510(k) clearances on record.