| K-number | K250197 |
| Device name | Estremo Fibular Nail |
| Applicant | Citieffe S.R.L. |
| Product code | HSB |
| Device class | Class II |
| Decision date | Oct 17, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3020 |
The Estremo Fibular Nail is an intramedullary fixation device composed of 316L stainless steel intended for use in the fixation of fibula fractures and osteotomies. It includes nails, screws, end caps, and related instruments provided in sterile condition.
The device is an angled nail that allows use of one or two syndesmotic screws with proximal and distal locking mechanisms. The key distinguishing feature is a 'Diapason wings deployment' mechanism at the proximal end that allows proximal fixation with a screw, differentiating it from traditional nails. Device lengths extend beyond the range of the primary predicate.
ASTM F1264 (intramedullary fixation device testing) and ASTM F543 (screw testing). Testing included static torsion, driving torque, pull-out, self-tapping performance, bending fatigue, four-point bend tests, and fatigue testing with corrosion assessment.
Substantial equivalence is based on identical intended use (fibula fracture and osteotomy fixation), same materials (316L stainless steel), similar technological characteristics (angled nail with proximal/distal locking and syndesmotic screw capability), and supportive performance testing demonstrating the device performs as intended. Clinical data were not required.
View the full FDA submission: accessdata.fda.gov