510(k) · Cleared
Recalled · 2010Ebi Aray 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 Oct 6, 2006 as substantially equivalent to K061563 (Ebi, L.P., 2006) and 2 other predicates after a 28-day review. Its family tree reaches back 1 generation to 1994. 28 later devices descend from it. It has been recalled once.
- Decided
- Oct 6, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K941367 (1994). 3 ancestors in all. 28 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK941367 Webb-Morley Spine SystemElectro-Biology, Inc. · 1994
- This deviceK062685 Ebi Aray Spinal SystemEbi, L.P. · 2006
- Descendant · cites it directly · 24 of its ownK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
- Descendant · 2 generations on · 21 of its ownK080767 Conquest Spinal SystemLife Spine · 2008
- Descendant · 3 generations on · 17 of its ownK123373 Nautilus Spinal SystemLife Spine · 2013
- Descendant · 4 generations on · 14 of its ownK132760 Nautilus Spinal SystemLife Spine, Inc. · 2013
- Descendant · 3 generations on · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K073430Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008 · cites it directly24descendants
- K080767Conquest Spinal SystemLife Spine · 2008 · 2 generations on21descendants
- K123373Nautilus Spinal SystemLife Spine · 2013 · 3 generations on17descendants
- K132760Nautilus Spinal SystemLife Spine, Inc. · 2013 · 4 generations on14descendants
- K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941367 | Webb-Morley Spine System | Electro-Biology, Inc. | 1994 | — |
| 0 (this device) | K062685 | Ebi Aray Spinal System | Ebi, L.P. | 2006 | — |
| +1 | K073430 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2008 | — |
| +2 | K080767 | Conquest Spinal System | Life Spine | 2008 | — |
| +3 | K123373 | Nautilus Spinal System | Life Spine | 2013 | — |
| +4 | K132760 | Nautilus Spinal System | Life Spine, Inc. | 2013 | — |
| +3 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 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? (3)
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 |
|---|---|---|---|
| * | K061563 | Ebi Array Spinal SystemSummary page 1…050, 21 CFR 888.3070, 21 CFR 888.3060 PREDICATE DEVICES: EBI® Array® Spinal System (Stainless Steel), K061563 EBI® Array® Spinal Fixation System, K033312 (… | 2006 |
| * | K033312 | Ebi Top Loading Mas Spinal Fixation SystemSummary page 1…ICATE DEVICES: EBI® Array® Spinal System (Stainless Steel), K061563 EBI® Array® Spinal Fixation System, K033312 (formerly referred to as 'Top Loading MAS Spinal… | 2004 |
| * | K941367 | Webb-Morley Spine SystemSummary page 1…ferred to as 'Top Loading MAS Spinal Fixation System') EBI® Webb Morley Spine System, K941367 INTENDED/INDICATIONS FOR USE: The Array® Spinal System is a non-cervical spinal fixation device intended for u… | 1994 |
What descends from it? (28)
See all 283 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2010 | Not classified | Z-0131-2011 | Other | One of the two connector ends of the medium cross connector may not be fully secured to the rod after tightening. This may not be readily apparent to the operating surgeon, resulting in inadequate torsional stability. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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/K062685 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062685: Ebi Aray 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/K062685
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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