# K013468: Long Length Dyax Nail

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Nov 16, 2001 after 29 days
- Product code: HSB (Rod, Fixation, Intramedullary And Accessories)
- Device class: 2
- Regulation: 21 CFR 888.3020
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
70 later devices descend from it; 1 cites it directly.
0 of 71 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) Long Length Gamma® Nail System: named in the summary without a submission number

## Most influential descendants
- K034002: GAMMA3 Nail System (2004), 69 descendants of its own
- K043431: GAMMA3 Nail System (2005), 48 descendants of its own
- K102992: T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 Degrees (2010), 37 descendants of its own
- K123401: GAMMA3 and T2 Recon Targeting Devices (2013), 20 descendants of its own
- K172774: T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System (2018), 17 descendants of its own

## Recalls of this device
- Sep 7, 2004 · Not classified · Z-0256-06: Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.

## Indications for use
The product is intended to be used in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point approximately 10 cm proximal to the intracondylar notch. Fracture types include basilar neck, intertrochanteric, subtrochanteric fractures and femoral shaft fractures. These femoral fractures may occur as a result of trauma; non-union, mal-union, pathological fractures, and impending pathological fractures.

Source page: https://510kreport.com/device/K013468
Methodology: https://510kreport.com/methodology