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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 / March 2026 / K253591

510(k) cleared

Phantom® Hindfoot TTC/TC Nail System

Paragon 28, Inc. · Mar 5, 2026 · K253591

FDA cleared the Phantom® Hindfoot TTC/TC Nail System from Paragon 28, Inc. on Mar 5, 2026 under K253591, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Nov 17, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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), K253613 (Monkey Rings External Ring Fixation System).

Questions & Answers

What did FDA clear under K253591?

K253591 is the FDA 510(k) for Phantom® Hindfoot TTC/TC Nail System, submitted by Paragon 28, Inc.. FDA's decision date was Mar 5, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Phantom® Hindfoot TTC/TC Nail System?

Paragon 28, Inc., based in Englewood, CO, is the applicant of record for K253591.

How long did the K253591 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Mar 5, 2026, 108 days later.

← All decisions in March 2026

Sources