# K091309: Revolution Femoral Intramedullary Nail System, Model Dgooxx

- Pathway: 510(k) (Traditional)
- Applicant: Dgimed Ortho, Inc.
- Decided: Nov 5, 2009 after 185 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 K893377 (1989). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893377: Russell-Taylor Intramedullary Knee Fusion Nails, Richards Medical Co., Inc. (1989) Summary page 1.
- K033618: Synthes (Usa) Retrograde/Antegrade Femoral Nail System, Synthes (Usa) (2004) Summary page 1.
- K912930: Interlocking Femoral Nailing System, Stryker Corp. (1992) Summary page 1.

## Most influential descendants
- K100312: Distalock Femoral Intramedullary Nail System (2010), 0 descendants of its own

## Indications for use
The Revolution Femoral Intramedullary Nail System is indicated for use in orthopaedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple traumna patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or imalunions and nonunions.

Source page: https://510kreport.com/device/K091309
Methodology: https://510kreport.com/methodology