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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 / K252025

510(k) cleared

Active Intramedullary (AIM) Tibial Nail System

Satori Orthopaedics, Inc. · Mar 4, 2026 · K252025

FDA cleared the Active Intramedullary (AIM) Tibial Nail System from Satori Orthopaedics, Inc. on Mar 4, 2026 under K252025, a traditional 510(k). The device falls under product code HSB, Rod, Fixation, Intramedullary And Accessories, regulated at 21 CFR 888.3020 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jun 30, 2025. The decision came 247 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 Satori Orthopaedics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252025?

K252025 is the FDA 510(k) for Active Intramedullary (AIM) Tibial Nail System, submitted by Satori Orthopaedics, Inc.. FDA's decision date was Mar 4, 2026, under product code HSB (Rod, Fixation, Intramedullary And Accessories).

Who makes the Active Intramedullary (AIM) Tibial Nail System?

Satori Orthopaedics, Inc., based in Phoenix, AZ, is the applicant of record for K252025.

How long did the K252025 review take?

FDA received the submission on Jun 30, 2025 and issued its decision on Mar 4, 2026, 247 days later.

← All decisions in March 2026