# K062066: Omega 3 System

- Pathway: 510(k) (Special)
- Applicant: Howmedica Osteonics Corp.
- Decided: Aug 15, 2006 after 25 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 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 Plus System: named in the summary without a submission number
- (no number) Omega 2 System: named in the summary without a submission number

## Most influential descendants
- K172872: DePuy Synthes Femoral Neck System (2018), 2 descendants of its own
- K182154: Depuy Synthes Femoral Neck System (2018), 1 descendant of its own
- K181640: X-BOLT Hip Fracture Fixation System (2018), 1 descendant of its own
- K230764: OsteoCentric Integrated Hip Fastener System (2023), 0 descendants of its own
- K221621: Pro-X1™ Trochanteric Nailing System (2023), 0 descendants of its own

## Indications for use
The Omega TM Plus, Omega TM 2, and Omega TM 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/K062066
Methodology: https://510kreport.com/methodology