Cleared Traditional

Active Intramedullary (AIM) Tibial Nail System

K252025 · Satori Orthopaedics, Inc. · Orthopedic

Mar 2026

Decision

247d

Days

Class 2

Risk

About This 510(k) Submission

K252025 is an FDA 510(k) clearance for the Active Intramedullary (AIM) Tibial Nail System, a Rod, Fixation, Intramedullary And Accessories (Class II — Special Controls, product code HSB), submitted by Satori Orthopaedics, Inc. (Phoenix, US). The FDA issued a Cleared decision on March 4, 2026, 247 days after receiving the submission on June 30, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3020.

Submission Details

510(k) Number	K252025 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2025
Decision Date	March 04, 2026
Days to Decision	247 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF