# K081278: Omega 3 Trochanteric Stabilizing Plate

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: May 29, 2008 after 23 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 its predicate without a number.
- (no number) Omega 3 System: named in the summary without a submission number

## Most influential descendants
- K083582: Sign Hip Construct (SHC), Model: 701 (2009), 2 descendants of its own
- K153759: SIGN Compression Screw System (2016), 0 descendants of its own
- K152757: SIGN Hip Construct (SHC) (2015), 0 descendants of its own

## Indications for use
The Omega Plus, Omega 2, and Omega 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: * 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/K081278
Methodology: https://510kreport.com/methodology