Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Active Intramedullary (AIM) Tibial Nail System

K-Number: K252025 · 2026-03-04

ApplicantSatori Orthopaedics, Inc.
Decision Date2026-03-04
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Active Intramedullary (AIM) Tibial Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Satori Orthopaedics, Inc.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K252025. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Active Intramedullary (AIM) Tibial Nail System?

Active Intramedullary (AIM) Tibial Nail System is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is Satori Orthopaedics, Inc.. The 510(k) number is K252025.

When did Active Intramedullary (AIM) Tibial Nail System receive FDA 510(k) clearance?

Active Intramedullary (AIM) Tibial Nail System received FDA 510(k) clearance on 2026-03-04, under 510(k) number K252025.

Who is the listed applicant for Active Intramedullary (AIM) Tibial Nail System?

The FDA 510(k) record lists Satori Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Active Intramedullary (AIM) Tibial Nail System?

The FDA product code for Active Intramedullary (AIM) Tibial Nail System is HSB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06976801Tibial IMN Vs. Tibial Micromotion IMNRECRUITING

Related Devices (Code: HSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑