# K020677: Gamma 3 Lag Screw

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Mar 29, 2002 after 28 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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) Dyax Nail Lag Screw: named in the summary without a submission number

## Most influential descendants
- K103400: Fluoromap Software, 9 Fluorodisc (Belt), 12 Fluoro Disc (Belt), Close Tube Clip (2011), 5 descendants of its own
- K173946: ADAPT for Gamma3 (2018), 2 descendants of its own
- K182359: HipCheck (2018), 1 descendant of its own
- K181848: ADAPT for Gamma3, Gamma3 (2018), 1 descendant of its own
- K230045: HipCheck (2023), 0 descendants of its own

## Indications for use
The Gamma 3 Lag Screw is intended to be used with both the Long Length Dyax Nail and the Trochanteric Dyax Nail. Intended Use for the Long Length Dyax 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. Intended Use for the Trochanteric Dyax Nail The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.

Source page: https://510kreport.com/device/K020677
Methodology: https://510kreport.com/methodology