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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 / November 2025 / K251709

510(k) cleared

MedCAD® AccuStride System

Medcad · Nov 4, 2025 · K251709

FDA cleared the MedCAD® AccuStride System from Medcad on Nov 4, 2025 under K251709, a traditional 510(k). The device falls under product code PBF, Orthopaedic Surgical Planning And Instrument Guides, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 3, 2025. The decision came 154 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medcad has one other decision in the tracker over the last 12 months: K252064 (MedCAD® AccuStride System).

Questions & Answers

What did FDA clear under K251709?

K251709 is the FDA 510(k) for MedCAD® AccuStride System, submitted by Medcad. FDA's decision date was Nov 4, 2025, under product code PBF (Orthopaedic Surgical Planning And Instrument Guides).

Who makes the MedCAD® AccuStride System?

Medcad, based in Dallas, TX, is the applicant of record for K251709.

How long did the K251709 review take?

FDA received the submission on Jun 3, 2025 and issued its decision on Nov 4, 2025, 154 days later.

← All decisions in November 2025

Sources