510(k) · Cleared
ClearedEbi Array Spinal Fixation System and Spinelink II Spinal Fixation Device
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 Dec 13, 2004 as substantially equivalent to K033312 (Ebi, L.P., 2004) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Dec 13, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K964159 (1997). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK964159 CD Spinal SystemSofamor Danek USA,Inc. · 1997
- 1 generation backK031355 Ebi Spinelink - II Spinal Fixation SystemEbi, L.P. · 2003
- This deviceK042772 Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation…Ebi, L.P. · 2004
- Descendant · cites it directly · 2 of its ownK070530 Modification to Passmed Spinal SystemMedicrea Technologies · 2007
- Descendant · 2 generations on · 1 of its ownK190376 PASS LP Spinal SystemMedicrea International SA · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK213281 PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
Most influential descendants
Showing 3 of 3 · See all- K070530Modification to Passmed Spinal SystemMedicrea Technologies · 2007 · cites it directly2descendants
- K190376PASS LP Spinal SystemMedicrea International SA · 2019 · 2 generations on1descendant
- K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964159 | CD Spinal System | Sofamor Danek USA,Inc. | 1997 | — |
| −1 | K031355 | Ebi Spinelink - II Spinal Fixation System | Ebi, L.P. | 2003 | — |
| 0 (this device) | K042772 | Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation Device | Ebi, L.P. | 2004 | — |
| +1 | K070530 | Modification to Passmed Spinal System | Medicrea Technologies | 2007 | — |
| +2 | K190376 | PASS LP Spinal System | Medicrea International SA | 2019 | 5 |
| +3 | K213281 | PASS LP™ Spinal System, CD Horizon™ Spinal System | Medicrea International SA | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K033312 | Ebi Top Loading Mas Spinal Fixation SystemSummary page 1…Arthroscope 3. Predicate or legally marketed devices that are substantially equivalent: EBI® Array TM Spinal Fixation System (K033312) 4. Description of the device: The EBI® Array Spinal Fixation System is a single use… | 2004 |
| * | K012516 | Ebi Spinelink - II Spinal Fixation SystemSummary page 4…Arthroscope 3. Predicate or legally marketed devices that are substantially equivalent: * EBI® SpineLink® Ii Spinal Fixation System (K012516) * EBI® SpineLink® II Spinal Fixation System (K031355) 4. Description of the device: The… | 2001 |
| * | K031355 | Ebi Spinelink - II Spinal Fixation SystemSummary page 4…antially equivalent: * EBI® SpineLink® Ii Spinal Fixation System (K012516) * EBI® SpineLink® II Spinal Fixation System (K031355) 4. Description of the device: The EBI® SpineLink® - ILSpinal Fixation System is a fixation device that utiliz… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070530 | Modification to Passmed Spinal System | 2007 | 2 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K070530 (Medicrea Technologies, 2007) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K033312.
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 EBI® Array™ Spinal Fixation 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…
Read the full statement (260 words)
The EBI® Array™ Spinal Fixation 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), spondytolisthesis, trauma, (i.e., fracture or dislocation), deformities or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.
The EBI® VuePASS™ Portal Access System when used with the EBI® Array™ Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The EBI® SpineLink H1 Spinal Fixation 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), deformities or curvatures (i.e.. scoliosis, kyphosis, and lordosis), tumor, stenosis, psuedoarthrosis, and failed previous fusion.
The EBI® VuePASS™ Portal Access System when used with the EBI® SpineLink® II Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042772 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042772: Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042772
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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