510(k) · Cleared
ClearedOmega 21 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi Electro Biology · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 24, 1997 after an 89-day review. The FDA summary names its predicate without a number. 45 later devices descend from it.
- Decided
- Dec 24, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
45 later devices descend from it, 5 citing it directly.
- This deviceK973683 Omega 21 SystemEbi Electro Biology · 1997
- Descendant · cites it directly · 44 of its ownK990303 Ebi Omega 21 SystemElectro-Biology, Inc. · 1999
- Descendant · cites it directly · 43 of its ownK014137 Modification to Ebi Omega 21 SystemEbi, L.P. · 2002
- Descendant · cites it directly · 40 of its ownK131250 Tiger Spine SystemCorelink, LLC · 2013
- Descendant · 2 generations on · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
- Descendant · 3 generations on · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K990303Ebi Omega 21 SystemElectro-Biology, Inc. · 1999 · cites it directly44descendants
- K014137Modification to Ebi Omega 21 SystemEbi, L.P. · 2002 · cites it directly43descendants
- K131250Tiger Spine SystemCorelink, LLC · 2013 · cites it directly40descendants
- K133369Tiger Spine SystemCorelink, LLC · 2014 · 2 generations on29descendants
- K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973683 | Omega 21 System | Ebi Electro Biology | 1997 | — |
| +1 | K990303 | Ebi Omega 21 System | Electro-Biology, Inc. | 1999 | — |
| +1 | K014137 | Modification to Ebi Omega 21 System | Ebi, L.P. | 2002 | — |
| +1 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| +2 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| +3 | K153453 | Inertia Pedicle Screw and Deformity Correxxion System | Nexxt Spine, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 5 | 0 |
| 2025 | 9 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Webb-Morley Spine System - Electro-Biology, Inc. Named without a submission number | |
| * | — | Isola® Spinal System - AcroMed Corporation Named without a submission number | |
| * | — | TSRH® Spinal System - Sofamor Danek Named without a submission number | |
| * | — | Osteonics® Spinal System - Osteonics Corporation Named without a submission number | |
| * | — | SpineLLink™ System - Electro-Biology, Inc. Named without a submission number |
What descends from it? (45)
See all 455 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K990303 (Electro-Biology, Inc., 1999) has gone furthest, with 44 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (201 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973683 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973683: Omega 21 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973683
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026