# K031354: Ebi OMEGA21 Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Aug 6, 2003 after 99 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964159 (1997). 3 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013887: Bacfix Spinal Fixation System, Spinal Concepts, Inc. (2002) Summary page 1.
- K964159: CD Spinal System, Sofamor Danek USA,Inc. (1997) Summary page 1.
- K983706: Modification of Townley Pedicle Screw Plating System, Sofamor Danek USA,Inc. (1998) Summary page 1.

## Most influential descendants
- K082353: Mercury Spinal System (2009), 11 descendants of its own
- K083230: Mercury Spinal System (2008), 11 descendants of its own
- K091587: Mercury Spinal System (2009), 10 descendants of its own
- K141372: Mercury Spinal System (2014), 9 descendants of its own
- K151215: Mercury Spinal System (2015), 8 descendants of its own

## Indications for use
The EBI Omega2 1 Spinal Fixation System is a non-celvical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacraYiliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by hstory and rahographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K031354
Methodology: https://510kreport.com/methodology