510(k) · Cleared
ClearedEbi Spinelink - II Spinal Fixation 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 Jul 22, 2003 as substantially equivalent to K013887 (Spinal Concepts, Inc., 2002) and 2 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Jul 22, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K964159 (1997). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK964159 CD Spinal SystemSofamor Danek USA,Inc. · 1997
- This deviceK031355 Ebi Spinelink - II Spinal Fixation SystemEbi, L.P. · 2003
- Descendant · cites it directly · 3 of its ownK042772 Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation…Ebi, L.P. · 2004
- Descendant · 2 generations on · 2 of its ownK070530 Modification to Passmed Spinal SystemMedicrea Technologies · 2007
- Descendant · 3 generations on · 1 of its ownK190376 PASS LP Spinal SystemMedicrea International SA · 2019 · Recalled
- Descendant · 4 generations on · 0 of its ownK213281 PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022
Most influential descendants
Showing 4 of 4 · See all- K042772Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation DeviceEbi, L.P. · 2004 · cites it directly3descendants
- K070530Modification to Passmed Spinal SystemMedicrea Technologies · 2007 · 2 generations on2descendants
- K190376PASS LP Spinal SystemMedicrea International SA · 2019 · 3 generations on1descendant
- K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA · 2022 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964159 | CD Spinal System | Sofamor Danek USA,Inc. | 1997 | — |
| 0 (this device) | K031355 | Ebi Spinelink - II Spinal Fixation System | Ebi, L.P. | 2003 | — |
| +1 | K042772 | Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation Device | Ebi, L.P. | 2004 | — |
| +2 | K070530 | Modification to Passmed Spinal System | Medicrea Technologies | 2007 | — |
| +3 | K190376 | PASS LP Spinal System | Medicrea International SA | 2019 | 5 |
| +4 | 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 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K013887 | Bacfix Spinal Fixation System | 2002 |
| * | K964159 | CD Spinal SystemSummary page 1…marketed devices that are substantially equivalent: 0 Spinal Concepts BacFix Spinal Fixation System (KO 13887) 0 Sofamor Danek CD Spinal System (K964159) 0 Sofamor Danek Townley Pedicle Screw Plating System (K983706) 4. Description of the device: The EBI@SpineLink@- I… | 1997 |
| * | K983706 | Modification of Townley Pedicle Screw Plating SystemSummary page 1…oncepts BacFix Spinal Fixation System (KO 13887) 0 Sofamor Danek CD Spinal System (K964159) 0 Sofamor Danek Townley Pedicle Screw Plating System (K983706) 4. Description of the device: The EBI@SpineLink@- I1 Spinal Fixation System is a spinal fixation device that utilizes inter… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042772 | Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation Device | 2004 | 3 |
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?
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@SpineLink@I1 Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacraViliac 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 (108 words)
The EBI@SpineLink@I1 Spinal Fixation System is a non-cervical spinal fixation device intended for use as a pedicle screw fixation system, a posterior hook and sacraViliac 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 or lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion. The transverse connector is not intended for anteriodanterolateral fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031355 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031355: Ebi Spinelink - II Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031355
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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