# K973683: Omega 21 System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi Electro Biology
- Decided: Dec 24, 1997 after 89 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
No predicates in its family tree.
45 later devices descend from it; 5 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)
- None. The FDA summary names its predicate without a number.
- (no number) Webb-Morley Spine System - Electro-Biology, Inc.: named in the summary without a submission number
- (no number) Isola® Spinal System - AcroMed Corporation: named in the summary without a submission number
- (no number) TSRH® Spinal System - Sofamor Danek: named in the summary without a submission number
- (no number) Osteonics® Spinal System - Osteonics Corporation: named in the summary without a submission number
- (no number) SpineLLink™ System - Electro-Biology, Inc.: named in the summary without a submission number

## Most influential descendants
- K990303: Ebi Omega 21 System (1999), 44 descendants of its own
- 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

## Indications for use
The Omega 21™ System is a spinal fixation device for pedicle screw fixation and nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine. When used as a pedicle screw fixation system, 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 autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine, and (d) who are having the device removed after the development of a solid fusion mass. The screws of the system are limited to L3- S1 or iliac screw fixation with the fusion only at L5-S1. When used as an unterior fixation system or as a posterior hook and sacral/iliac screw fixation system, the system is indicated for nonpedicle spinal applications for the reduction, alignment or stabilization of the thoracic, lumbar and sacral segments of the spine, in cases of: Degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K973683
Methodology: https://510kreport.com/methodology