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The Tracker / January 2026 / K253178

510(k) cleared

TRILEAP Plating System

Crossroads Extremity Systems · Jan 6, 2026 · K253178

FDA cleared the TRILEAP Plating System from Crossroads Extremity Systems on Jan 6, 2026 under K253178, 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 Sep 26, 2025. The decision came 102 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Crossroads Extremity Systems in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253178?

K253178 is the FDA 510(k) for TRILEAP Plating System, submitted by Crossroads Extremity Systems. FDA's decision date was Jan 6, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the TRILEAP Plating System?

Crossroads Extremity Systems, based in Memphis, TN, is the applicant of record for K253178.

How long did the K253178 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jan 6, 2026, 102 days later.

← All decisions in January 2026