510(k) K251052

Trivicta® Hip Stem by Ortho Development Corp. — Product Code MEH

K251052 is an FDA 510(k) premarket notification submitted by Ortho Development Corp. for the device "Trivicta® Hip Stem". The FDA issued a decision of Substantially Equivalent on May 22, 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. Ortho Development Corp. has at least 10 other 510(k) clearances on record.