# K013524: Trochanteric Dyax Nail System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 14, 2001 after 22 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.
132 later devices descend from it; 3 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Trochanteric Gamma® Nail System: named in the summary without a submission number

## Most influential descendants
- K040212: Trigen Intertan (2004), 121 descendants of its own
- K051557: Trigen Retrograde Femoral, Supracondylar and Tibial Nails (2005), 69 descendants of its own
- K061019: Trigen Meta-Nail Retrograde Femoral and Tibial Nails (2006), 60 descendants of its own
- K080434: Intertan CHS Locking Plate System Prox Fem Plates/Screw (2008), 35 descendants of its own
- K090656: Intertan CHS Limited Collapse Set Screw (2009), 34 descendants of its own

## Indications for use
The device is intended for use in stabilizing various types of intertrochanteric fractures of the proximal femur.

Source page: https://510kreport.com/device/K013524
Methodology: https://510kreport.com/methodology