# K230456: SGM Femoral Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
- Decided: Jun 30, 2023 after 129 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
Longest line of descent: 1 generation back to K011857 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011857: Synthes (Usa) Trochanteric Fixation Nail (TFN) System, Synthes (Usa) (2001) Summary page 4.

## Indications for use
SGM Femoral Nail System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long SGM Femoral Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

Source page: https://510kreport.com/device/K230456
Methodology: https://510kreport.com/methodology