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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 / October 2025 / K250316

510(k) cleared

Meduloc Intramedullary Fracture Fixation (IFF) System

Meduloc, LLC · Oct 29, 2025 · K250316 · In the directory

FDA cleared the Meduloc Intramedullary Fracture Fixation (IFF) System from Meduloc, LLC on Oct 29, 2025 under K250316, a traditional 510(k). The device falls under product code JDW, Pin, Fixation, Threaded, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 4, 2025. The decision came 267 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Meduloc, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250316?

K250316 is the FDA 510(k) for Meduloc Intramedullary Fracture Fixation (IFF) System, submitted by Meduloc, LLC. FDA's decision date was Oct 29, 2025, under product code JDW (Pin, Fixation, Threaded).

Who makes the Meduloc Intramedullary Fracture Fixation (IFF) System?

Meduloc, LLC, based in Del Mar, CA, is the applicant of record for K250316. The company is listed in the MedDevice Startups directory.

How long did the K250316 review take?

FDA received the submission on Feb 4, 2025 and issued its decision on Oct 29, 2025, 267 days later.

← All decisions in October 2025

Sources

In the startup directory

Meduloc

Orthopedics & Spine · West Chester, PA