Estremo Fibular Nail
by Citieffe s.r.l. 510(k)
Active
510(k) K250197
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK250197 | Date17 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HSB
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3020
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Estremo Fibular Nail is an intramedullary orthopedic device designed for the fixation of fibula fractures and osteotomies. It belongs to the category of intramedullary nails, specifically intended for long bone stabilization. The device features a proximal tip with a patented wing-expansion mechanism, enhancing proximal stability through a ‘Diapason wings deployment’ system. This design allows for secure anchoring within the bone, reducing displacement risk during healing.
The Estremo Fibular Nail is supplied as a single-use, sterile device and is intended for use in orthopedic surgical settings. It is classified under FDA product code HSB and received a Traditional 510(k) clearance via the Orthopedic (OR) Advisory Committee. The nail is manufactured by Citieffe s.r.l. in Calderara Di Reno, Italy, and must be handled according to standard aseptic protocols. No MRI safety information is specified, and storage conditions align with typical orthopedic implant requirements.
Other devices from Citieffe s.r.l.
Questions
AI-generated answers, 1 Oct 2026
What is the Estremo Fibular Nail used for?
The Estremo Fibular Nail is designed specifically for the fixation of fibula fractures and osteotomies. Its intramedullary placement stabilizes long bone healing, with a key innovation being the proximal ‘Diapason wings’ mechanism. This wing-expansion system improves anchorage in the bone, reducing displacement risk during the recovery period. It is ideal for orthopedic surgeons treating complex fibula injuries requiring secure internal stabilization.
How is the Estremo Fibular Nail supplied and what are its sterility and reuse details?
The Estremo Fibular Nail is supplied as a single-use, sterile device, adhering to standard orthopedic implant sterility protocols. It is not intended for reuse, as single-use devices are engineered for one surgical procedure to ensure patient safety and prevent cross-contamination. Always follow aseptic handling procedures during preparation and implantation to maintain sterility.
Does the Estremo Fibular Nail have different sizes or models?
The provided device data does not specify multiple sizes or models for the Estremo Fibular Nail. However, intramedullary nails like this typically come in various lengths or diameters to accommodate different patient anatomies. For precise sizing, refer to the manufacturer’s surgical technique guide or consult Citieffe s.r.l. directly, as they may offer tailored options based on clinical requirements.
What storage conditions should be followed for the Estremo Fibular Nail?
The Estremo Fibular Nail should be stored according to standard orthopedic implant requirements, which generally include protection from moisture, extreme temperatures, and physical damage. Store in a clean, dry environment, away from direct sunlight or sources of contamination. Ensure the packaging remains intact until immediate preoperative use to preserve sterility and functionality.
Is there any MRI safety information available for the Estremo Fibular Nail?
The device data does not provide explicit MRI safety information for the Estremo Fibular Nail. If MRI imaging is required post-surgery, consult the manufacturer’s guidelines or a radiology specialist to assess potential risks. Metallic implants like this nail may interact with magnetic fields, so caution is advised unless otherwise specified.