DeviceClearance

FITBONE® TRANSPORT AND LENGTHENING SYSTEM— 510(k) K260146

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K260146 for FITBONE® TRANSPORT AND LENGTHENING SYSTEM, Substantially Equivalent on 2026-05-19. Applicant: Orthofix Srl. Device class: 2.

Summary

Orthofix's FITBONE Transport and Lengthening System is filed under HSB, intramedullary fixation rods and accessories.

Class II, 21 CFR 888.3020. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).

Orthofix filed from Bussolengo (Vr), Italy. Review took 119 calendar days (January 20 to May 19, 2026).

Clearance details

Applicant
Orthofix Srl
Product code
Product code HSB
Device class
Class 2
Regulation
21 CFR 888.3020
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bussolengo (Vr), IT
Download summary PDFView on FDA.gov ↗

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Adverse events under product code HSB

product code HSB
Death
49
Injury
12,083
Malfunction
6,561
Other
1
Total
18,694

Source: openFDA MAUDE database, through . 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.