Skip to content

Mpact 3D Metal Augments II

by Medacta International S.A.

510(k) K242232

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242232 Date23 Apr 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LPH
Device Class
Class II
Regulation
21 CFR Part 888.3358
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Mpact 3D Metal Augments II is an orthopedic device used in joint reconstruction procedures. It is designed to augment bone defects in orthopedic applications, providing structural support where bone loss has occurred.

The device is supplied non-sterile and intended for single-use. It is manufactured by Medacta International S.A. and received FDA 510(k) clearance under K242232 with product code LPH. The device is not MRI safe unless explicitly stated, and no sterility, size, or storage details are provided in the data.

Other devices from Medacta International S.A.

See all devices from Medacta International S.A. →