SMART Osteotomy System— 510(k) K260090

Name: FDA 510(k) clearance K260090
Creator: U.S. Food and Drug Administration
Published: 2026-04-10

Substantially Equivalent

Actis Medical Pty., Ltd.

FDA 510(k) clearance K260090 for SMART Osteotomy System, Substantially Equivalent on 2026-04-10. Applicant: Actis Medical Pty., Ltd.. Device class: 2.

Summary

The SMART Osteotomy System is filed under HRS, bone fixation plates. The record doesn't say which bone the system is for.

Class II, 21 CFR 888.3030. The Orthopedic panel reviewed it as a Traditional 510(k).

Actis Medical filed from Torrensville, Australia. Review took 88 days (January 12 to April 10, 2026).

Clearance details

Applicant: Actis Medical Pty., Ltd.
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2026-01-12
Decision date: 2026-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrensville, AU

Download summary PDF View on FDA.gov ↗

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K262963 — TMC Implant Fixation System2026-09-15

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.