# K013132: Sign IM Nail

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Implant Generation Network (Sign)
- Decided: Dec 20, 2001 after 92 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) Smith & Nephew “TriGen®” Knee Nail: named in the summary without a submission number
- (no number) ACE Medical “AIM” Titanium Tibial Nail: named in the summary without a submission number
- (no number) Synthes “Universal Nail”: named in the summary without a submission number

## Indications for use
The SIGN IM Nail is indicated for internal fixation of diaphyseal tibial fractures and distal femur fractures including Transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions.

Source page: https://510kreport.com/device/K013132
Methodology: https://510kreport.com/methodology