# K181540: Estremo Citieffe Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Citieffe S.R.L.
- Decided: Jan 16, 2019 after 219 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Estremo Citieffe Nailing System is indicated for femoral fracture fixation, which may include the following: • diaphyseal femoral fractures; • supra-condylar femoral fractures; • corrective osteotomies; • pseudoarthrosis; • non-unions and mal-unions. The Estremo Citieffe Nailing System is indicated for tibial fracture fixation, which may include the following: • diaphyseal tibial fractures; • corrective osteotomies; • pseudoarthrosis; • non-unions and mal-unions. The Estremo Citieffe Nailing System is indicated for tibiotalocalcaneal arthrodesis.

Source page: https://510kreport.com/device/K181540
Methodology: https://510kreport.com/methodology