# K991405: Omni-Fix, Humeral Nail

- Pathway: 510(k) (Traditional)
- Applicant: Turnkey Intergration USA, Inc.
- Decided: Jun 29, 1999 after 68 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. The FDA summary names its predicate without a number.
- (no number) Biomet, Uniflex nail system: named in the summary without a submission number

## Indications for use
Cases of fracture of the long arm bones are not uncommon and are usually caused by trauma. The surgical re-construction of the humeral is necessary to restore the patients natural alignment of the arm. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections together, until natural healing of the fracture occurs. The nail creates a sound foundation when the fracture is healed for full load bearing.

Source page: https://510kreport.com/device/K991405
Methodology: https://510kreport.com/methodology