# K023204: Modification to Ebi OMEGA21 Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Ebi, L.P.
- Decided: Oct 18, 2002 after 23 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 4 generations back to K973683 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020681: Ebi OMEGA21 Spinal Fixation System, Ebi, L.P. (2002) Summary page 1.
- K014137: Modification to Ebi Omega 21 System, Ebi, L.P. (2002) Summary page 1.
- K001357: Modification to Omega 21 System, Ebi, L.P. (2000)
- K992333: Ebi Omega 21 System, Electro-Biology, Inc. (1999) Summary page 1.
- K991721: Ebi Omega 21 System, Ebi Electro Biology (1999) Summary page 1.
- K990303: Ebi Omega 21 System, Electro-Biology, Inc. (1999) Summary page 1.
- K973683: Omega 21 System, Ebi Electro Biology (1997) Summary page 1.

## Indications for use
The EBI@Omega2ITM Spinal Fixation System is a spinal fixation device for pedicle screw fixation and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine. When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5 - SI) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection. When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.

Source page: https://510kreport.com/device/K023204
Methodology: https://510kreport.com/methodology