# K152757: SIGN Hip Construct (SHC)

- Pathway: 510(k) (Traditional)
- Applicant: Sign Fracture Care International
- Decided: Nov 13, 2015 after 50 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: 2 generations back to K972108 (1997). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083582: Sign Hip Construct (SHC), Model: 701, Surgical Implant Generation Network (Sign) (2009) Summary page 4.
- K022632: Sign IM Nail, Surgical Implant Generation Network (Sign) (2002) Summary page 4.
- K021932: Synthes 6.5 MM Cannulated Screw, Synthes (Usa) (2002) Summary page 4.

## Indications for use
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric, reverse oblique, subtrochanteric fractures and osteotomies in the proximal femur, with proper soft tissue management.

Source page: https://510kreport.com/device/K152757
Methodology: https://510kreport.com/methodology