# K990307: Omni-Fix, Nail System

- Pathway: 510(k) (Traditional)
- Applicant: Turnkey Intergration USA, Inc.
- Decided: Apr 1, 1999 after 59 days
- Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Cases of fracture of the long leg bones are not uncommon and are usually caused by trauma. The surgical re-construction of either the tibia or femur is necessary to restore the patient back their natural alignment and gait. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections in alignment until natural healing occurs. The nails creates a sound foundation for the partial, then when healed full load bearing.

Source page: https://510kreport.com/device/K990307
Methodology: https://510kreport.com/methodology