Satori Orthopaedics, Inc. · Class II · Cleared Mar 4, 2026
| K-number | K252025 |
| Device name | Active Intramedullary (AIM) Tibial Nail System |
| Applicant | Satori Orthopaedics, Inc. |
| Product code | HSB |
| Device class | Class II |
| Decision date | Mar 4, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The Active Intramedullary (AIM) Tibial Nail System is a tibial intramedullary fixation rod made from titanium alloy with an internal compression spring. It is indicated for treating open or closed tibial shaft fractures, including proximal/distal fractures, various fracture patterns, non-unions, malunions, and pathologic or impending fractures.
The AIM Tibial Nail System possesses the same intended use and technological characteristics as predicate devices. The key distinguishing feature is an internal compression spring for compression force and axial movement, integrated within the titanium alloy nail design with interlocking screws.
ASTM F1264 (static and dynamic mechanical testing of the nail), ASTM F543 (static and dynamic mechanical testing of the screws), compression fatigue testing of the spring, corrosion evaluation, and particulate debris evaluation.
The AIM Tibial Nail System is substantially equivalent to predicate devices because it shares the same intended use, indications for use, and technological characteristics. Nonclinical testing including mechanical, fatigue, corrosion, and debris evaluations support adequate device performance and substantial equivalence to the predicates.
View the full FDA submission: accessdata.fda.gov