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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 / K260323

510(k) cleared

OrthoPediatrics® Locking Cannulated Blade Plate System

OrthoPediatrics Corp. · Apr 30, 2026 · K260323

FDA cleared the OrthoPediatrics® Locking Cannulated Blade Plate System from OrthoPediatrics Corp. on Apr 30, 2026 under K260323, a traditional 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jan 30, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

OrthoPediatrics Corp. has one other decision in the tracker over the last 12 months: K252600 (Pediatric Plating Platform I Small-Mini).

Questions & Answers

What did FDA clear under K260323?

K260323 is the FDA 510(k) for OrthoPediatrics® Locking Cannulated Blade Plate System, submitted by OrthoPediatrics Corp.. FDA's decision date was Apr 30, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the OrthoPediatrics® Locking Cannulated Blade Plate System?

OrthoPediatrics Corp., based in Warsaw, IN, is the applicant of record for K260323.

How long did the K260323 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Apr 30, 2026, 90 days later.

← All decisions in April 2026

Sources