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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 / October 2025 / K252600

510(k) cleared

Pediatric Plating Platform I Small-Mini

OrthoPediatrics Corp. · Oct 9, 2025 · K252600

FDA cleared the Pediatric Plating Platform I Small-Mini from OrthoPediatrics Corp. on Oct 9, 2025 under K252600, 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 Aug 18, 2025. The decision came 52 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: K260323 (OrthoPediatrics® Locking Cannulated Blade Plate System).

Questions & Answers

What did FDA clear under K252600?

K252600 is the FDA 510(k) for Pediatric Plating Platform I Small-Mini, submitted by OrthoPediatrics Corp.. FDA's decision date was Oct 9, 2025, under product code HRS (Plate, Fixation, Bone).

Who makes the Pediatric Plating Platform I Small-Mini?

OrthoPediatrics Corp., based in Warsaw, IN, is the applicant of record for K252600.

How long did the K252600 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Oct 9, 2025, 52 days later.

← All decisions in October 2025

Sources