# K252025: Active Intramedullary (AIM) Tibial Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Satori Orthopaedics, Inc.
- Decided: Mar 4, 2026 after 247 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K000684 (2000). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170972: Apex Tibial Nailing System, Orthoxel (2017) Summary page 5.
- K083458: Intramedullary Fixation Rod (Ifs), Novalign Orthopaedics, Inc. (2009). Our reading of the summary gave K083459, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NovaLign Intramedullary Fixation System”.
- K113828: Dynanail Ankle Arthrodesis Nail, MedShape, Inc. (2012) Summary page 5.
- K082770: Zimmer Natural Nail System Tibial Nail, Zimmer, Inc. (2008) Summary page 5.
- K202099: AOS Galileo™ Trochanteric Nail System, Advanced Orthopaedic Solutions, Inc. (2020) Summary page 5.

## Indications for use
The Active Intramedullary (AIM) Tibial Nail System is indicated for the following: * Open or closed fractures of the tibial shaft * Proximal or distal tibial shaft fractures * Tibial shaft fractures including transverse, short oblique, long oblique, and comminuted fracture patterns * Tibial non-unions and malunions * Pathologic and/or impending fractures

Source page: https://510kreport.com/device/K252025
Methodology: https://510kreport.com/methodology