WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K260146

510(k) cleared

FITBONE® TRANSPORT AND LENGTHENING SYSTEM

Orthofix Srl · May 19, 2026 · K260146

FDA cleared the FITBONE® TRANSPORT AND LENGTHENING SYSTEM from Orthofix Srl on May 19, 2026 under K260146, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 20, 2026. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Orthofix Srl has 2 other decisions in the tracker over the last 12 months: K253991 (Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA), K252088 (Firebird SI Navigation System).

Questions & Answers

What did FDA clear under K260146?

K260146 is the FDA 510(k) for FITBONE® TRANSPORT AND LENGTHENING SYSTEM, submitted by Orthofix Srl. FDA's decision date was May 19, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the FITBONE® TRANSPORT AND LENGTHENING SYSTEM?

Orthofix Srl, based in Bussolengo (Vr), is the applicant of record for K260146.

How long did the K260146 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on May 19, 2026, 119 days later.

← All decisions in May 2026

Sources