# K990303: Ebi Omega 21 System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Apr 29, 1999 after 87 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- 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 K973683 (1997). 1 ancestor in all.
44 later devices descend from it; 4 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973683: Omega 21 System, Ebi Electro Biology (1997) Summary page 1.

## Most influential descendants
- K014137: Modification to Ebi Omega 21 System (2002), 43 descendants of its own
- K131250: Tiger Spine System (2013), 40 descendants of its own
- K133369: Tiger Spine System (2014), 29 descendants of its own
- K153453: Inertia Pedicle Screw and Deformity Correxxion System (2016), 17 descendants of its own
- K192121: Black Diamond Pedicle Screw System (2019), 13 descendants of its own

## Indications for use
The EBI Omega 21™ System és a spinal fixcation device for pedicle screw fixation and a nonpedicle hook and sacralf iliac screw fixation system of the noncervical 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 fasled previous fusion (psuedarthrosis). 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-S1) vertebral joint; (b) who are receiving fusions using antogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and () who are having the device removed afer the development of a solid fusion mass. When used as a posterior hook and sacrall iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogentc origin with degeneration of the disc confirmed by history and radiographic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthests, fracture; previous failed fusion; or tumor resection. When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodses 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 studses). Psuedarthrosis; stenosis; scoliosis; spondylolisthesis, fracture; previous fasled Juston; or tumor resection.

Source page: https://510kreport.com/device/K990303
Methodology: https://510kreport.com/methodology