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The Tracker / September 2026 / K261892

510(k) cleared

ProRib Fixation System

Costa Surgical, Inc. · Sep 23, 2026 · K261892

FDA cleared the ProRib Fixation System from Costa Surgical, Inc. on Sep 23, 2026 under K261892, 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 5, 2026. The decision came 110 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 Costa Surgical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261892?

K261892 is the FDA 510(k) for ProRib Fixation System, submitted by Costa Surgical, Inc.. FDA's decision date was Sep 23, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the ProRib Fixation System?

Costa Surgical, Inc., based in Chandler, AZ, is the applicant of record for K261892.

How long did the K261892 review take?

FDA received the submission on Jun 5, 2026 and issued its decision on Sep 23, 2026, 110 days later.

← All decisions in September 2026