Fusion Orthopedics USA, LLC · Class II · Cleared Mar 18, 2026
| K-number | K252961 |
| Device name | Fusion FibFix Nail |
| Applicant | Fusion Orthopedics USA, LLC |
| Product code | HSB |
| Device class | Class II |
| Decision date | Mar 18, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The Fusion FibFix Nail is a titanium alloy intramedullary nail system intended for fixation of fibula fractures and osteotomies. The system includes fibula nails (3.7mm to 5.7mm diameter, 130-270mm length), threaded bone fixation screws (2.7mm diameter), end caps, and surgical instruments for insertion and removal. It is for single-use implantation and may be used with adjunctive syndesmotic fixation devices.
The Fusion FibFix Nail and predicate devices are manufactured from titanium alloy (ASTM F136) and are compatible with similar-sized nails, having equivalent widths, thickness, lengths, and designs. Both systems operate on the same intramedullary fixation principle with comparable features and intended uses for ankle fixation following trauma and osteotomy.
ASTM F136 (titanium alloy material specification). Engineering rational validation, static and dynamic testing, and validations on cleaning, packaging, and sterilization of implants and instruments were performed.
Substantial equivalence is based on similarities in principles of operation, technology, materials (both titanium alloy ASTM F136), and identical indications for use. Non-clinical testing demonstrated substantially equivalent performance. The devices have compatible design and functional characteristics for fibula fracture and osteotomy fixation.
View the full FDA submission: accessdata.fda.gov