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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 / August 2026 / K261121

510(k) cleared

Megalodon Dynamic Compression System

Paragon 28, Inc. · Aug 6, 2026 · K261121

FDA cleared the Megalodon Dynamic Compression System from Paragon 28, Inc. on Aug 6, 2026 under K261121, a traditional 510(k). The device falls under product code JDR, Staple, 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 Apr 3, 2026. The decision came 125 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: K262047 (Grappler Suture Anchor System), K253886 (Grappler Suture Anchor PCFD Tether System), K253591 (Phantom® Hindfoot TTC/TC Nail System), K253613 (Monkey Rings External Ring Fixation System).

Questions & Answers

What did FDA clear under K261121?

K261121 is the FDA 510(k) for Megalodon Dynamic Compression System, submitted by Paragon 28, Inc.. FDA's decision date was Aug 6, 2026, under product code JDR (Staple, Fixation, Bone).

Who makes the Megalodon Dynamic Compression System?

Paragon 28, Inc., based in Centennial, CO, is the applicant of record for K261121.

How long did the K261121 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Aug 6, 2026, 125 days later.

← All decisions in August 2026