# K020773: Long Length Gamma Nail

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 4, 2002 after 27 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.
No later device cites it as a predicate yet.
0 of 1 device 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: named in the summary without a submission number

## 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 intercondylar 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/K020773
Methodology: https://510kreport.com/methodology