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THE TAPE

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 / July 2026 / K262075

510(k) cleared

Lapidus Screw Kit

Relja Innovations, LLC · Jul 22, 2026 · K262075

FDA cleared the Lapidus Screw Kit from Relja Innovations, LLC on Jul 22, 2026 under K262075, a special 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 Jun 22, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Relja Innovations, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262075?

K262075 is the FDA 510(k) for Lapidus Screw Kit, submitted by Relja Innovations, LLC. FDA's decision date was Jul 22, 2026, under product code HWC (Screw, Fixation, Bone).

Who makes the Lapidus Screw Kit?

Relja Innovations, LLC, based in Wauwatosa, WI, is the applicant of record for K262075.

How long did the K262075 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Jul 22, 2026, 30 days later.

← All decisions in July 2026