Cleared Traditional

Mpact Constrained Liner

K241461 · Medacta International S.A. · Orthopedic

Jul 2025

Decision

434d

Days

Class 2

Risk

About This 510(k) Submission

K241461 is an FDA 510(k) clearance for the Mpact Constrained Liner, a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II — Special Controls, product code KWZ), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on July 31, 2025, 434 days after receiving the submission on May 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3310.

Submission Details

510(k) Number	K241461 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2024
Decision Date	July 31, 2025
Days to Decision	434 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3310