510(k) · Cleared
ClearedEbi Array Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 23, 2006 after an 18-day review. The FDA summary names its predicate without a number. 275 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
275 later devices descend from it, 5 citing it directly.
- This deviceK061563 Ebi Array Spinal SystemEbi, L.P. · 2006
- Descendant · cites it directly · 255 of its ownK081952 Synergy Spinal System (6.35 Polaris)Biomet Spine · 2008
- Descendant · cites it directly · 156 of its ownK090523 Polaris Spinal SystemEbi, L.P. · 2009
- Descendant · cites it directly · 154 of its ownK090203 5.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P. · 2009
- Descendant · 2 generations on · 153 of its ownK100220 Polaris Spinal SystemEbi, L.P. · 2010
- Descendant · 2 generations on · 144 of its ownK100409 Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation…Biomet Spine (Aka Ebi, LLC) · 2010
Showing 5 of 275 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 275 · See all- K081952Synergy Spinal System (6.35 Polaris)Biomet Spine · 2008 · cites it directly255descendants
- K090523Polaris Spinal SystemEbi, L.P. · 2009 · cites it directly156descendants
- K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P. · 2009 · cites it directly154descendants
- K100220Polaris Spinal SystemEbi, L.P. · 2010 · 2 generations on153descendants
- K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemBiomet Spine (Aka Ebi, LLC) · 2010 · 2 generations on144descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061563 | Ebi Array Spinal System | Ebi, L.P. | 2006 | — |
| +1 | K081952 | Synergy Spinal System (6.35 Polaris) | Biomet Spine | 2008 | — |
| +1 | K090523 | Polaris Spinal System | Ebi, L.P. | 2009 | — |
| +1 | K090203 | 5.5 Helical Flange Spinal System, Polaris Components | Ebi, L.P. | 2009 | — |
| +2 | K100220 | Polaris Spinal System | Ebi, L.P. | 2010 | — |
| +2 | K100409 | Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System | Biomet Spine (Aka Ebi, LLC) | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 16 | 0 |
| 2014 | 16 | 0 |
| 2015 | 20 | 0 |
| 2016 | 14 | 0 |
| 2017 | 15 | 0 |
| 2018 | 19 | 0 |
| 2019 | 13 | 0 |
| 2020 | 16 | 0 |
| 2021 | 15 | 0 |
| 2022 | 18 | 0 |
| 2023 | 25 | 0 |
| 2024 | 26 | 0 |
| 2025 | 23 | 0 |
| 2026 | 17 | 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 NKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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® Array® Spinal Fixation System (formerly referred to as 'Top Loading MAS Spinal… Named without a submission number | |
| * | — | EBI® Webb Morley Spine System Named without a submission number | |
| * | — | Interpore Cross International Synergy Spinal System (Posterior) Named without a submission number | |
| * | — | Interpore Cross International Synergy Spinal System (Anterior) Named without a submission number |
What descends from it? (275)
See all 2755 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, K081952 (Biomet Spine, 2008) has gone furthest, with 255 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The Array Spinal System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated for all of the following indications regardless of the intended use; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, (i.e., fracture or dislocation), deformity or curvature (i.e., scoliosis, kyphosis, and/or lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061563 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061563: Ebi Array Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061563
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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