Mpact 3D Metal Augments II— 510(k) K242232

Name: FDA 510(k) clearance K242232
Creator: U.S. Food and Drug Administration
Published: 2025-04-23

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K242232 for Mpact 3D Metal Augments II, Substantially Equivalent on 2025-04-23. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code LPH
Device class: Class 2
Regulation: 21 CFR 888.3358
Advisory panel: Orthopedic
Date received: 2024-07-30
Decision date: 2025-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code LPH

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K253630 — Mpact 3D Metal Foam2026-08-28
K254043 — TRIVANCE Hip Stem2026-08-04
K261624 — Omnifit® 20° Series I Insert +11 more2026-07-10
K243192 — iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating2026-06-05
K251270 — Taperloc® Complete Hip Stem2026-05-19

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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
K251043 — Mpact 3D Metal Implants Extension DMLS Technology2026-01-28

Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.