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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 / April 2026 / K261043

510(k) cleared

AUTOBAHN Nailing System

Globus Medical, Inc. · Apr 24, 2026 · K261043

FDA cleared the AUTOBAHN Nailing System from Globus Medical, Inc. on Apr 24, 2026 under K261043, a special 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 Mar 31, 2026. The decision came 24 days later, inside the 90 FDA-day goal for a 510(k).

Globus Medical, Inc. has 7 other decisions in the tracker over the last 12 months: K254043 (TRIVANCE Hip Stem), K262251 (ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)), K253739 (SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System), K253401 (SCRIPT Implant System).

Questions & Answers

What did FDA clear under K261043?

K261043 is the FDA 510(k) for AUTOBAHN Nailing System, submitted by Globus Medical, Inc.. FDA's decision date was Apr 24, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the AUTOBAHN Nailing System?

Globus Medical, Inc., based in Audubon, PA, is the applicant of record for K261043.

How long did the K261043 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Apr 24, 2026, 24 days later.

← All decisions in April 2026