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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 / October 2025 / K252088

510(k) cleared

Firebird SI Navigation System

Orthofix US, LLC · Oct 31, 2025 · K252088

FDA cleared the Firebird SI Navigation System from Orthofix US, LLC on Oct 31, 2025 under K252088, a traditional 510(k). The device falls under product code OLO, Orthopedic Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jul 2, 2025. The decision came 121 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Orthofix US, LLC has 2 other decisions in the tracker over the last 12 months: K260146 (FITBONE® TRANSPORT AND LENGTHENING SYSTEM), K253991 (Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA).

Questions & Answers

What did FDA clear under K252088?

K252088 is the FDA 510(k) for Firebird SI Navigation System, submitted by Orthofix US, LLC. FDA's decision date was Oct 31, 2025, under product code OLO (Orthopedic Stereotaxic Instrument).

Who makes the Firebird SI Navigation System?

Orthofix US, LLC, based in Lewisville, TX, is the applicant of record for K252088.

How long did the K252088 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Oct 31, 2025, 121 days later.

← All decisions in October 2025

Sources