510(k) K241461

Mpact Constrained Liner by Medacta International S.A. — Product Code KWZ

K241461 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "Mpact Constrained Liner". The FDA issued a decision of Substantially Equivalent on July 31, 2025. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. Medacta International S.A. has at least 10 other 510(k) clearances on record.