# K181375: Apex Femoral Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Orthoxel
- Decided: Jul 17, 2018 after 54 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
Longest line of descent: 6 generations back to K970097 (1997). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172114: Zimmer Natural Nail System, Zimmer, Inc. (2017) Summary page 5.

## Indications for use
The Apex Femoral Nailing system is intended for temporary fixation and stabilization of the fractures of the femur. The Apex nail is indicated for used in adult patients for treatment of: * Open and closed fractures, including simple, severely comminuted, spiral, large oblique, and segmental fractures; * Fractures involving osteopenic or osteoporotic bone; * Fractures with bone loss; * Pseudoarthosis, nonunion, and malunion; * Correction osteotomy; * Pathologic fractures and prophylactic nailing of impending pathologic fractures; * Periprosthetic fractures; * Closed supracondylar fractures (retrograde only) and: * Intertrochanteric and subtrochanteric fractures (antegrade only)

Source page: https://510kreport.com/device/K181375
Methodology: https://510kreport.com/methodology