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The Tracker / September 2026 / K262057

510(k) cleared

GMK Extension

Medacta International SA · Sep 15, 2026 · K262057

FDA cleared the GMK Extension from Medacta International SA on Sep 15, 2026 under K262057, a traditional 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 18, 2026. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Medacta International SA has 8 other decisions in the tracker over the last 12 months: K260173 (M-Vizion Femoral Revision System Extension), K253630 (Mpact 3D Metal Foam), K261016 (MSS - Humeral reverse liners extension), K254202 (MectaLIF 3D Metal Anterior).

Questions & Answers

What did FDA clear under K262057?

K262057 is the FDA 510(k) for GMK Extension, submitted by Medacta International SA. FDA's decision date was Sep 15, 2026, under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer).

Who makes the GMK Extension?

Medacta International SA, based in Castel San Pietro, is the applicant of record for K262057.

How long did the K262057 review take?

FDA received the submission on Jun 18, 2026 and issued its decision on Sep 15, 2026, 89 days later.

← All decisions in September 2026