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FDA 510(k)

Mpact 3D Metal Implants Extension – DMLS Technology

K-Number: K251043 · 2026-01-28

ApplicantMedacta International S.A.
Decision Date2026-01-28
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mpact 3D Metal Implants Extension – DMLS Technology is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2026-01-28 under 510(k) number K251043. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mpact 3D Metal Implants Extension – DMLS Technology?

Mpact 3D Metal Implants Extension – DMLS Technology is a medical device that received FDA 510(k) clearance on 2026-01-28. The listed applicant is Medacta International S.A.. The 510(k) number is K251043.

When did Mpact 3D Metal Implants Extension – DMLS Technology receive FDA 510(k) clearance?

Mpact 3D Metal Implants Extension – DMLS Technology received FDA 510(k) clearance on 2026-01-28, under 510(k) number K251043.

Who is the listed applicant for Mpact 3D Metal Implants Extension – DMLS Technology?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mpact 3D Metal Implants Extension – DMLS Technology?

The FDA product code for Mpact 3D Metal Implants Extension – DMLS Technology is LPH.

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Other records listing Medacta International S.A. as applicant

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Related Devices (Code: LPH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K252067Velora Acetabular SystemRestor3D, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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