# K012158: Modification to: Long Length Gamma Nail

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 1, 2001 after 21 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.
14 later devices descend from it; 1 cites it directly.
0 of 15 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: named in the summary without a submission number

## Most influential descendants
- K021008: Advanced Orthopaedic Solutions Trochanteric Nail (2002), 13 descendants of its own
- K103533: ES Trochanteric Nail, Left and Right, 10MM (2011), 11 descendants of its own
- K120148: Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw (2012), 6 descendants of its own
- K202099: AOS Galileo™ Trochanteric Nail System (2020), 4 descendants of its own
- K140601: Flow-Nail (2014), 2 descendants of its own

## Indications for use
The intended use of the modified Long Length Gamma® Nail is identical to that of the predicate Long Length Gamma® Nail: 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/K012158
Methodology: https://510kreport.com/methodology