# K083458: Intramedullary Fixation Rod (Ifs)

- Pathway: 510(k) (Traditional)
- Applicant: Novalign Orthopaedics, Inc.
- Decided: Feb 9, 2009 after 80 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K252025: Active Intramedullary (AIM) Tibial Nail System (2026), 0 descendants of its own

## Indications for use
The NovaLignTM Intramedullary Fixation System is intended for use in the fixation of long bone fractures, including fractures in the humerus, femur and the tibia.

Source page: https://510kreport.com/device/K083458
Methodology: https://510kreport.com/methodology