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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 / K252312

510(k) cleared

Eleganz IM Threaded Nail System (IM Threaded Nail System)

Dev4 · Oct 10, 2025 · K252312

FDA cleared the Eleganz IM Threaded Nail System (IM Threaded Nail System) from Dev4 on Oct 10, 2025 under K252312, a traditional 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 24, 2025. The decision came 78 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Dev4 in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252312?

K252312 is the FDA 510(k) for Eleganz IM Threaded Nail System (IM Threaded Nail System), submitted by Dev4. FDA's decision date was Oct 10, 2025, under product code HWC (Screw, Fixation, Bone).

Who makes the Eleganz IM Threaded Nail System (IM Threaded Nail System)?

Dev4, based in Houston, TX, is the applicant of record for K252312.

How long did the K252312 review take?

FDA received the submission on Jul 24, 2025 and issued its decision on Oct 10, 2025, 78 days later.

← All decisions in October 2025