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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 / K250536

510(k) cleared

MetaFore Small Screw System

Extremity Medical, LLC · Oct 8, 2025 · K250536

FDA cleared the MetaFore Small Screw System from Extremity Medical, LLC on Oct 8, 2025 under K250536, a traditional 510(k). The device falls under product code HWC, Screw, Fixation, Bone, regulated at 21 CFR 888.3040 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 24, 2025. The decision came 226 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 Extremity Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250536?

K250536 is the FDA 510(k) for MetaFore Small Screw System, submitted by Extremity Medical, LLC. FDA's decision date was Oct 8, 2025, under product code HWC (Screw, Fixation, Bone).

Who makes the MetaFore Small Screw System?

Extremity Medical, LLC, based in Parsippany, NJ, is the applicant of record for K250536.

How long did the K250536 review take?

FDA received the submission on Feb 24, 2025 and issued its decision on Oct 8, 2025, 226 days later.

← All decisions in October 2025