# K233910: Vertex Hip Fracture Nailing System

- Pathway: 510(k) (Traditional)
- Applicant: Orthoxel Dac
- Decided: Apr 4, 2024 after 114 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). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183162: Affixus Hip Fracture Nail, Biomet, Inc. (2018) Summary page 5.
- K040212: Trigen Intertan, Smith & Nephew, Inc. (2004) Summary page 5.

## Indications for use
The Vertex Hip Fracture Nailing System is intended for temporary fixation and stabilization of stable and unstable fractures of the proximal femur. The Vertex Nail is indicated for use in adult patients for treatment of: • Pertrochanteric fractures; • Intertrochanteric fractures; • High subtrochanteric fractures • Combinations of the above fractures, including non-union, malunion and tumor resections. The Long Nail system is additionally indicated for use in adult patients for treatment of: • Pertrochanteric fractures associated with shaft fractures; • Pathologic fractures in osteoporotic bone (including prophylactic use) of the trochanteric and diaphyseal areas; • Impending pathological fractures; • Long subtrochanteric fractures; • Ipsilateral femoral fractures; • Proximal or distal non-unions, malunions, revision procedures and tumor resections.

Source page: https://510kreport.com/device/K233910
Methodology: https://510kreport.com/methodology