| K-number | K252196 |
| Device name | Arthrex FibuLock Nail System |
| Applicant | Arthrex, Inc. |
| Product code | HSB |
| Device class | Class II |
| Decision date | Mar 5, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The Arthrex FibuLock Nail System is an intramedullary fixation device used to treat fibula fractures and osteotomies. It comprises FibuLock Nails (made of 316L stainless steel with proximal fixation grippers called talons), headless cortical screws, end caps, and buttress plates. The system can be used alone or with other FDA-cleared Arthrex devices for enhanced stabilization.
The FibuLock Nail features a proximal diameter of 3.0–3.8 mm, a 6-degree lateral bend, and talon grippers for proximal fixation without screws. The system offers longer nail lengths and additional end cap sizes (3 mm, 5 mm) compared to predicates. Headless cortical screws range from 2.7–3.8 mm diameter and 10–65 mm in length. Buttress plates are available in 2-hole and 3-hole configurations, and the system has been evaluated for MR Conditional labeling.
ASTM F138 (stainless steel), ASTM F1264 (intramedullary fixation devices), ASTM F543 (metallic bone screws), ISO 13485 (design controls and corrective/preventative actions), ISO 10993-1:2018 (biocompatibility), ASTM F2052, F2119, F2182, F2213 (MR safety testing), and FDA guidance on orthopedic non-spinal metallic bone screws.
View the full FDA submission: accessdata.fda.gov