510(k) · Cleared
ClearedModification to Ebi Omega 21 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jan 16, 2002 as substantially equivalent to K001357 (Ebi, L.P., 2000) and 4 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1997. 43 later devices descend from it.
- Decided
- Jan 16, 2002
- Review
- 30 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K973683 (1997). 5 ancestors in all. 43 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK973683 Omega 21 SystemEbi Electro Biology · 1997
- 1 generation backK990303 Ebi Omega 21 SystemElectro-Biology, Inc. · 1999
- This deviceK014137 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
- Descendant · 4 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 5 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- 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
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 4 generations on13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973683 | Omega 21 System | Ebi Electro Biology | 1997 | — |
| −1 | K990303 | Ebi Omega 21 System | Electro-Biology, Inc. | 1999 | — |
| 0 (this device) | 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 | — |
| +4 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +5 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 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 |
|---|---|---|---|
| * | K001357 | Modification to Omega 21 SystemSummary page 1…ebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: » EBI Omega 21™ System (K001357, K992333, K991721, K990303, and K973683) 4. Description of the device: The EBI Omega 21™ System is a spinal fixation device that… | 2000 |
| * | K992333 | Ebi Omega 21 SystemSummary page 1…y Fixation Orthosis Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: » EBI Omega 21™ System (K001357, K992333, K991721, K990303, and K973683) 4. Description of the device: The EBI Omega 21™ System is a spinal fixation device that uses rod… | 1999 |
| * | K991721 | Ebi Omega 21 SystemSummary page 1…n Orthosis Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: » EBI Omega 21™ System (K001357, K992333, K991721, K990303, and K973683) 4. Description of the device: The EBI Omega 21™ System is a spinal fixation device that uses rods, screws… | 1999 |
| * | K990303 | Ebi Omega 21 SystemSummary page 1…s Spinal Interlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: » EBI Omega 21™ System (K001357, K992333, K991721, K990303, and K973683) 4. Description of the device: The EBI Omega 21™ System is a spinal fixation device that uses rods, screws, coupler… | 1999 |
| * | K973683 | Omega 21 SystemSummary page 1…erlaminal Fixation Orthosis 3. Predicate or legally marketed devices that are substantially equivalent: » EBI Omega 21™ System (K001357, K992333, K991721, K990303, and K973683) 4. Description of the device: The EBI Omega 21™ System is a spinal fixation device that uses rods, screws, couplers, and hooks.… | 1997 |
What descends from it? (43)
See all 433 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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K131250 (Corelink, LLC, 2013) has gone furthest, with 40 descendants of its own.
- 3 other devices also cite its predicate K001357.
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 EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation an icle 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…
Read the full statement (312 words)
The EBI Omega 21™ System is a spinal fixation device for pedicle screw fixation an icle 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 nuerologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion. (pseudoarthrosis).
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 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 limited to the sacrum and ilium. The system is intended for the treatment of degenerative disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, 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 disk disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudoarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection.
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/K014137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014137: Modification to Ebi Omega 21 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014137
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026