510(k) K242315

Resolve Modular Revision Hip Stem by United Orthopedic Corporation — Product Code MEH

K242315 is an FDA 510(k) premarket notification submitted by United Orthopedic Corporation for the device "Resolve Modular Revision Hip Stem". The FDA issued a decision of Substantially Equivalent on May 1, 2025. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. United Orthopedic Corporation has at least 10 other 510(k) clearances on record.