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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 / December 2025 / K253613

510(k) cleared

Monkey Rings External Ring Fixation System

Paragon 28, Inc. · Dec 19, 2025 · K253613

FDA cleared the Monkey Rings External Ring Fixation System from Paragon 28, Inc. on Dec 19, 2025 under K253613, a special 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 Nov 18, 2025. The decision came 31 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 K253613?

K253613 is the FDA 510(k) for Monkey Rings External Ring Fixation System, submitted by Paragon 28, Inc.. FDA's decision date was Dec 19, 2025, under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component).

Who makes the Monkey Rings External Ring Fixation System?

Paragon 28, Inc., based in Englewood, CO, is the applicant of record for K253613.

How long did the K253613 review take?

FDA received the submission on Nov 18, 2025 and issued its decision on Dec 19, 2025, 31 days later.

← All decisions in December 2025

Sources