Cleared Traditional

K260146 - FITBONE® TRANSPORT AND LENGTHENING SYSTEM

K260146 is an FDA 510(k) clearance for FITBONE TRANSPORT AND LENGTHENING SYSTEM, manufactured by Orthofix Srl. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K260146 · Orthofix Srl · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
119d
Days
Class 2
Risk

K260146 is an FDA 510(k) clearance for the FITBONE® TRANSPORT AND LENGTHENING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthofix Srl (Bussolengo (Vr), IT). The FDA issued a Cleared decision on May 19, 2026 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Orthofix Srl devices

FDA 510(k) Submission Details - K260146

510(k) Number K260146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2026
Decision Date May 19, 2026
Days to Decision 119 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K260146.
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