# K153759: SIGN Compression Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Sign Fracture Care International
- Decided: Feb 25, 2016 after 57 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K983641 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000080: Asnis Iii Cannulated Screw System, Howmedica Osteonics Corp. (2000) Summary page 4.
- K083582: Sign Hip Construct (SHC), Model: 701, Surgical Implant Generation Network (Sign) (2009) Summary page 4.

## Indications for use
Indications for the SIGN Compression Screw System include intracapsular femoral neck fractures, with proper soft tissue management.

Source page: https://510kreport.com/device/K153759
Methodology: https://510kreport.com/methodology