510(k) K250450

Coated hip implants by Medacta International S.A. — Product Code LZO

K250450 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "Coated hip implants". The FDA issued a decision of Substantially Equivalent on September 19, 2025. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Medacta International S.A. has at least 10 other 510(k) clearances on record.