# K971056: Magellan Magnetic Distal Targeting System (Proposed Name), Product Line Extension

- Pathway: 510(k) (Traditional)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Oct 3, 1997 after 193 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) Preamendments Intramedullary Nail Instrumentation (Wright Medical Technology, Inc.): named in the summary without a submission number
- (no number) Russell-Taylor Intramedullary Nail System Instrumentation (Smith and Nephew): named in the summary without a submission number

## Indications for use
The MAGELLAN™ Intramedullary Femoral Nail System is indicated for use in long bone shaft fractures of the femur which require stabilization of the axis of the bone, including subtrochanteric fractures, intertrochanteric fractures, femoral neck fractures, comminuted fractures, segmental fractures, fractures with bone loss, proximal and distal fractures, nonunions and malunions, and bone lengthening.

Source page: https://510kreport.com/device/K971056
Methodology: https://510kreport.com/methodology