# K001357: Modification to Omega 21 System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, L.P.
- Decided: Jul 20, 2000 after 83 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
44 later devices descend from it; 4 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K001357
Methodology: https://510kreport.com/methodology