Jeil Medical Corporation · Class II · Cleared Dec 10, 2025
| K-number | K252826 |
| Device name | ARIX Femur Nail System |
| Applicant | Jeil Medical Corporation |
| Product code | HSB |
| Device class | Class II |
| Decision date | Dec 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The ARIX Femur Nail System is an intramedullary fixation device used to treat stable and unstable fractures of the femur, as well as to stabilize bones and correct bone deformities in the intracapsular, trochanteric, subtrochanteric, and shaft regions. It can be used for osteoporotic and osteopenic bone. The device is provided in sterile or non-sterile form.
The Anti-Rotation Lag Screw and Telescopic Lag Screw are made of Titanium Alloy meeting ASTM F136, with the Anti-Rotation Pin section made of Nickel-Titanium Alloy meeting ASTM F2063. No significant differences exist between the subject device and predicate devices in shape, configuration, specification, materials, surface treatment, sterilization, biocompatibility, and performance.
ASTM F384-17 (Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices) covering full construction static and fatigue tests and corrosion assessment; ASTM F1264-16 Standard for cut-out performance testing.
View the full FDA submission: accessdata.fda.gov