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The Tracker / September 2025 / K251892

510(k) cleared

MAXXOS P.A.C.E. Foot & Ankle Plating System

Maxxos Medical GmbH · Sep 8, 2025 · K251892

FDA cleared the MAXXOS P.A.C.E. Foot & Ankle Plating System from Maxxos Medical GmbH on Sep 8, 2025 under K251892, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 20, 2025. The decision came 80 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Maxxos Medical GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251892?

K251892 is the FDA 510(k) for MAXXOS P.A.C.E. Foot & Ankle Plating System, submitted by Maxxos Medical GmbH. FDA's decision date was Sep 8, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the MAXXOS P.A.C.E. Foot & Ankle Plating System?

Maxxos Medical GmbH, based in Mahlstetten, is the applicant of record for K251892.

How long did the K251892 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Sep 8, 2025, 80 days later.

← All decisions in September 2025