# K133104: Van Hip Fracture System

- Pathway: 510(k) (Traditional)
- Applicant: Epix Orthopaedic, Corp.
- Decided: Mar 10, 2014 after 161 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: 2 generations back to K970097 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032244: Gamma 3 Nail System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K964880: Vari-Angle Hip Screw (VHS) System, Walter Abendschein, M.D. (1997) Summary page 1.
- K010988: Fixion Interlocking Proximal Femoral Nailing System, Disc-O-Tech Medical Technologies, Ltd. (2001) Summary page 1.

## Indications for use
The VAN Hip Fracture System is indicated for fixation of fractures of the femur, including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures and combinations of these fractures, pathological fractures in both diaphyseal and trochanteric areas, and nonunion or malunion.

Source page: https://510kreport.com/device/K133104
Methodology: https://510kreport.com/methodology