# K083582: Sign Hip Construct (SHC), Model: 701

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Implant Generation Network (Sign)
- Decided: Aug 26, 2009 after 265 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K983641 (1998). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043200: Sign Fin Nail, Surgical Implant Generation Network (Sign) (2005) Summary page 1.
- K983641: Holland Femoral Nail System, Biomet, Inc. (1998) Summary page 1.
- K052677: Synthes Universal Locking Trochanter Stabilization Plate (Ultsp), Synthes (Usa) (2005) Summary page 1.
- K081278: Omega 3 Trochanteric Stabilizing Plate, Howmedica Osteonics Corp. (2008) Summary page 1.
- K051624: T2 Recon Nail System, Howmedica Osteonics Corp. (2005) Summary page 1.
- K030377: Modification to Synthes Cervifix System, Synthes (Usa) (2003) Summary page 1.

## Most influential descendants
- K153759: SIGN Compression Screw System (2016), 0 descendants of its own
- K152757: SIGN Hip Construct (SHC) (2015), 0 descendants of its own

## Indications for use
Indications for the SIGN Hip Construct (SHC) include all peritrochanteric fractures of the hip with proper soft tissue management. This does not include femoral neck fractures and may include subtrochanteric fractures.

Source page: https://510kreport.com/device/K083582
Methodology: https://510kreport.com/methodology