Cleared Traditional

Versacem Acetabular Shell and Double Mobility HC Liners

K241767 · Medacta International S.A. · Orthopedic

Mar 2025

Decision

259d

Days

Class 2

Risk

About This 510(k) Submission

K241767 is an FDA 510(k) clearance for the Versacem Acetabular Shell and Double Mobility HC Liners, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on March 6, 2025, 259 days after receiving the submission on June 20, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K241767 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2024
Decision Date	March 06, 2025
Days to Decision	259 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353