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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 / September 2025 / K252106

510(k) cleared

External Fixation Mini Rail System

Paragon 28, Inc. · Sep 30, 2025 · K252106

FDA cleared the External Fixation Mini Rail System from Paragon 28, Inc. on Sep 30, 2025 under K252106, a traditional 510(k). The device falls under product code KTT, Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 3, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

Paragon 28, Inc. has 5 other decisions in the tracker over the last 12 months: K261121 (Megalodon Dynamic Compression System), K262047 (Grappler Suture Anchor System), K253886 (Grappler Suture Anchor PCFD Tether System), K253591 (Phantom® Hindfoot TTC/TC Nail System).

Questions & Answers

What did FDA clear under K252106?

K252106 is the FDA 510(k) for External Fixation Mini Rail System, submitted by Paragon 28, Inc.. FDA's decision date was Sep 30, 2025, under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Who makes the External Fixation Mini Rail System?

Paragon 28, Inc., based in Englewood, CO, is the applicant of record for K252106.

How long did the K252106 review take?

FDA received the submission on Jul 3, 2025 and issued its decision on Sep 30, 2025, 89 days later.

← All decisions in September 2025

Sources