Versacem Acetabular Shell and Double Mobility HC Liners— 510(k) K241767

Name: FDA 510(k) clearance K241767
Creator: U.S. Food and Drug Administration
Published: 2025-03-06

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K241767 for Versacem Acetabular Shell and Double Mobility HC Liners, Substantially Equivalent on 2025-03-06. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2024-06-20
Decision date: 2025-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZO

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K253948 — Momentum Acetabular Cup System2026-09-02
K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)2026-07-06
K260831 — Z1 Hip System2026-06-16
K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
K260037 — implantcast Packaging System Update2026-03-30

More clearances from Medacta International S.A.

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K253630 — Mpact 3D Metal Foam2026-08-28
K254202 — MectaLIF 3D Metal Anterior2026-05-05
K253940 — M.U.S.T. Pedicle Screw System - Extension2026-04-28
K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26
K250644 — MSS - Monobloc stem2026-02-03

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.