# K070454: Omega 3 Supracondylar Plate

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Apr 12, 2007 after 55 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
- (no number) Omega 2 System: named in the summary without a submission number

## Indications for use
The Omega TM Plus, Omega TM 2, and OmegaTM 3 Systems are intended for use in the temporary stabilization of types of fractures of the proximal and distal femur. The subject devices are indicated for fixation of proximal and distal femoral fractures including but not limited to: * Intracapsular and basal neck fractures including transcervical and subcapital fractures * Intertrochanteric fractures * Subtrochanteric fractures * Supracondylar fractures * Intracondylar fractures * Osteotomies for patients with diseases or deformities of the hip * Hip arthrodesis

Source page: https://510kreport.com/device/K070454
Methodology: https://510kreport.com/methodology