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FDA 510(k)

GMK 3D Metal Tibial Tray Extension

K-Number: K253328 · 2026-02-26

ApplicantMedacta International S.A.
Decision Date2026-02-26
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GMK 3D Metal Tibial Tray Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2026-02-26 under approval number K253328. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GMK 3D Metal Tibial Tray Extension?

GMK 3D Metal Tibial Tray Extension is a medical device that received FDA 510(k) clearance on 2026-02-26. It is manufactured by Medacta International S.A.. The 510(k) number is K253328.

When was GMK 3D Metal Tibial Tray Extension approved by the FDA?

GMK 3D Metal Tibial Tray Extension received FDA 510(k) clearance on 2026-02-26, under approval number K253328.

What company makes GMK 3D Metal Tibial Tray Extension?

GMK 3D Metal Tibial Tray Extension is manufactured by Medacta International S.A..

What is the FDA product code for GMK 3D Metal Tibial Tray Extension?

The FDA product code for GMK 3D Metal Tibial Tray Extension is MBH.

Related Clinical Trials

NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT06941558 The UK ADAPTIS Study ACTIVE_NOT_RECRUITING NCT07544264 Evaluation of 5-year Survival and Clinical Outcomes in Patients Undergoing Total Knee Arthroplasty With a Polyethylene Tibial Component NOT_YET_RECRUITING

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, 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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