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. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 27, 2001 after a 113-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Nov 27, 2001
- Review
- 113 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK012516 Ebi Spinelink - II Spinal Fixation SystemEbi, L.P. · 2001
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K012516 | Ebi Spinelink - II Spinal Fixation System | Ebi, L.P. | 2001 | — |
| +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 | — |
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 KWP? 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? (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 |
|---|---|---|---|
| * | — | EBI® SpineLink™ System Named without a submission number | |
| * | — | EBI® Omega 21™ System Named without a submission number | |
| * | — | Webb-Morley Spine System Named without a submission number |
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?
- Of its descendants, K042772 (Ebi, L.P., 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EBI® SpineLink™ - II Spinal Fixation System is a spinal fixation device for pedicle screw fixation, and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine, and an anterior fixation system. 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…
Read the full statement (331 words)
The EBI® SpineLink™ - II Spinal Fixation System is a spinal fixation device for pedicle screw fixation, and a non-pedicle hook and sacral/iliac screw fixation system of the non-cervical spine, and an anterior fixation system.
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 (pseudarthrosis).
In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar — first sacral (LS — S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior hook and sacral/iliac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation is 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 radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection.
When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. 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 radiographic studies); pseudarthrosis; stenosis; scoliosis; spondylolisthesis; fracture; previous failed fusion; or tumor resection. The transverse connector is not intended for anterior fixation.
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/K012516 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012516: Ebi Spinelink - II Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012516
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026