PC Fix System— 510(k) K260411

Name: FDA 510(k) clearance K260411
Creator: U.S. Food and Drug Administration
Published: 2026-04-24

Substantially Equivalent

Chest Wall Innovations, Inc.

FDA 510(k) clearance K260411 for PC Fix System, Substantially Equivalent on 2026-04-24. Applicant: Chest Wall Innovations, Inc.. Device class: 2.

Summary

Chest Wall Innovations' PC Fix System is filed under product code HRS (Plate, Fixation, Bone). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 888.3030. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Chest Wall Innovations filed from Hershey, Pennsylvania. The decision came 74 calendar days after FDA received it (February 9 to April 24, 2026).

Clearance details

Applicant: Chest Wall Innovations, Inc.
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-02-09
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hershey, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K263602 — Arthrex Plates, Screws and Pins, and Washers2026-10-29
K261135 — Trochlear Salvage Plating System2026-10-26
K262779 — ANTHEM Fracture System2026-10-23
K263407 — Tempo Plating System2026-10-23
K263269 — Park's Pectus System2026-10-15

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.