510(k) · Cleared
ClearedEbi Spinelink System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 23, 1999 after an 85-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Nov 23, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK992920 Ebi Spinelink SystemEbi, L.P. · 1999
- Descendant · cites it directly · 1 of its ownK133287 Presson Spinal Fixation SystemNexus Spine, LLC · 2014
- Descendant · cites it directly · 1 of its ownK071990 Valeo Cervical Plate SystemAmedica Corp. · 2007
- Descendant · 2 generations on · 0 of its ownK160820 PressON Pro Spinal Fixation SystemNexus Spine, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK082037 Seeplate Cervical Plate SystemAmedica Corp. · 2008
Most influential descendants
Showing 4 of 4 · See all- K133287Presson Spinal Fixation SystemNexus Spine, LLC · 2014 · cites it directly1descendant
- K071990Valeo Cervical Plate SystemAmedica Corp. · 2007 · cites it directly1descendant
- K160820PressON Pro Spinal Fixation SystemNexus Spine, LLC · 2016 · 2 generations on0descendants
- K082037Seeplate Cervical Plate SystemAmedica Corp. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992920 | Ebi Spinelink System | Ebi, L.P. | 1999 | — |
| +1 | K133287 | Presson Spinal Fixation System | Nexus Spine, LLC | 2014 | — |
| +1 | K071990 | Valeo Cervical Plate System | Amedica Corp. | 2007 | — |
| +2 | K160820 | PressON Pro Spinal Fixation System | Nexus Spine, LLC | 2016 | — |
| +2 | K082037 | Seeplate Cervical Plate System | Amedica Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 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 MNI? 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? (2)
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 |
|---|---|---|---|
| * | — | EBI SpineLink™ System Named without a submission number | |
| * | — | EBI Webb-Motley Spine System Named without a submission number |
What descends from it? (4)
2 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, K133287 (Nexus Spine, LLC, 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EBI SpineLink™ System és a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacralf iliac screw fixcation 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…
Read the full statement (312 words)
The EBI SpineLink™ System és a spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacralf iliac screw fixcation 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 failed 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 spondylolisthests (Grades 3 and 4) of the fifth lumbar - first sacral (L5-51) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device Jfixced or attached to the lumbar and sacral spine (L3 and below); and (@) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacralf 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 discogenic origin with degeneration of the disc confirmed by history and radiograpbic studies). Psuedarthrosis; stenosts; scoliosis; spondylolisthesis, Jracture; previous failed fusion; or tumor resection.
When used as an anterior fixcation system, the levels of attachment are the anterolateral vertebral bodses of the lumbar and thoradic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic orygin with degeneration of the disc confirmed by history and radiggraphic studies). Psuedarthrosis; stenosis; scoliosis; spondylolisthests, fracture; previous fasled 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/K992920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992920: Ebi Spinelink System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992920
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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