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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 / K253991

510(k) cleared

Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA

Orthofix Srl · May 8, 2026 · K253991

FDA cleared the Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA from Orthofix Srl on May 8, 2026 under K253991, 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 Dec 12, 2025. The decision came 147 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: K260146 (FITBONE® TRANSPORT AND LENGTHENING SYSTEM), K252088 (Firebird SI Navigation System).

Questions & Answers

What did FDA clear under K253991?

K253991 is the FDA 510(k) for Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA, submitted by Orthofix Srl. FDA's decision date was May 8, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?

Orthofix Srl, based in Bussolengo (Vr), is the applicant of record for K253991.

How long did the K253991 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on May 8, 2026, 147 days later.

← All decisions in May 2026

Sources