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Mpact 3D Metal Implants Extension – DMLS Technology

by Medacta International S.A.

510(k) K251043

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251043 Date28 Jan 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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.

The Mpact 3D Metal Implants Extension is a metal implant device utilizing DMLS (Direct Metal Laser Sintering) technology. This device is designed for orthopedic applications and serves as an extension component for the Mpact implant system.

The device is supplied as a single-use or reusable product depending on the specific model and is intended for surgical implantation. It is MRI conditional and requires proper storage conditions as specified by the manufacturer. The device has received FDA 510(k) clearance with product code LPH and is manufactured by Medacta International S.A.

Other devices from Medacta International S.A.

See all devices from Medacta International S.A. →

Questions

AI-generated answers, 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.

  • What is the Mpact 3D Metal Implants Extension used for?

    The Mpact 3D Metal Implants Extension is designed for orthopedic applications and serves as an extension component for the Mpact implant system, intended for surgical implantation.

  • Is the Mpact 3D Metal Implants Extension single-use or reusable?

    The device is supplied as either a single-use or reusable product depending on the specific model selected, with appropriate usage instructions provided by the manufacturer.

  • What regulatory approvals does the Mpact 3D Metal Implants Extension have?

    The device has received FDA 510(k) clearance with product code LPH, classified as substantially equivalent, and is MRI conditional, requiring proper storage as specified by the manufacturer.

  • What technology is used in the manufacturing of the Mpact 3D Metal Implants Extension?

    The implant utilizes DMLS (Direct Metal Laser Sintering) technology, which allows for precise manufacturing of complex metal components for orthopedic applications.