ProRib Fixation System— 510(k) K261892

Name: FDA 510(k) clearance K261892
Creator: U.S. Food and Drug Administration
Published: 2026-09-23

Substantially Equivalent

Costa Surgical, Inc.

FDA 510(k) clearance K261892 for ProRib Fixation System, Substantially Equivalent on 2026-09-23. Applicant: Costa Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Costa Surgical, Inc.
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-06-05
Decision date: 2026-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chandler, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

view all

K261611 — TDM Large Bone Plate and Screw System2026-10-02
K262649 — Alians Forearm2026-09-28
K262098 — EnHAnce PEEK Bunion System2026-09-18
K262963 — TMC Implant Fixation System2026-09-15
K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.