# K022632: Sign IM Nail

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Implant Generation Network (Sign)
- Decided: Sep 23, 2002 after 47 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 K972108 (1997). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010801: T2 Femoral Nail, Howmedica Osteonics Corp. (2001)
- K021026: S2 Femoral Nail, Howmedica Osteonics Corp. (2002)
- K972108: Alta Intramedullary Rod System, Howmedica Corp. (1997) Summary page 1.

## Most influential descendants
- K163589: SIGN IM Nail (2017), 0 descendants of its own
- K152757: SIGN Hip Construct (SHC) (2015), 0 descendants of its own

## 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 and fractures in the proximal femur.

Source page: https://510kreport.com/device/K022632
Methodology: https://510kreport.com/methodology