# K020772: Omega II System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Jun 5, 2002 after 89 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple 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) Omega+ Plus System: named in the summary without a submission number

## Indications for use
The Omega@II System is indicated for temporary stabilization of fractures of the proximal femur which may include the following: Intracapsular fractures of the femoral neck Intertrochanteric fractures

Source page: https://510kreport.com/device/K020772
Methodology: https://510kreport.com/methodology