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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 / March 2026 / K253517

510(k) cleared

Reselute Tibial Nail

Reselute, Inc. · Mar 10, 2026 · K253517

FDA cleared the Reselute Tibial Nail from Reselute, Inc. on Mar 10, 2026 under K253517, 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 Nov 12, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Reselute, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253517?

K253517 is the FDA 510(k) for Reselute Tibial Nail, submitted by Reselute, Inc.. FDA's decision date was Mar 10, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Reselute Tibial Nail?

Reselute, Inc., based in Durham, NC, is the applicant of record for K253517.

How long did the K253517 review take?

FDA received the submission on Nov 12, 2025 and issued its decision on Mar 10, 2026, 118 days later.

← All decisions in March 2026