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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 / March 2026 / K252064

510(k) cleared

MedCAD® AccuStride System

Medcad · Mar 27, 2026 · K252064

FDA cleared the MedCAD® AccuStride System from Medcad on Mar 27, 2026 under K252064, 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 Jul 1, 2025. The decision came 269 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: K251709 (MedCAD® AccuStride System).

Questions & Answers

What did FDA clear under K252064?

K252064 is the FDA 510(k) for MedCAD® AccuStride System, submitted by Medcad. FDA's decision date was Mar 27, 2026, 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 K252064.

How long did the K252064 review take?

FDA received the submission on Jul 1, 2025 and issued its decision on Mar 27, 2026, 269 days later.

← All decisions in March 2026

Sources