510(k) · Cleared
ClearedEbi Top Loading Mas 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 Jan 13, 2004 after a 91-day review. The FDA summary names its predicate without a number. 277 later devices descend from it.
- Decided
- Jan 13, 2004
- Review
- 91 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 0
277 later devices descend from it, 5 citing it directly.
- This deviceK033312 Ebi Top Loading Mas Spinal Fixation SystemEbi, L.P. · 2004
- Descendant · cites it directly · 156 of its ownK090523 Polaris Spinal SystemEbi, 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
- Descendant · cites it directly · 126 of its ownK082187 Biomet Anterior Lumbar PlateEbi, L.P. · 2008
- Descendant · 2 generations on · 113 of its ownK121791 Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012
Showing 5 of 277 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 277 · See all- K090523Polaris Spinal SystemEbi, L.P. · 2009 · cites it directly156descendants
- 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
- K082187Biomet Anterior Lumbar PlateEbi, L.P. · 2008 · cites it directly126descendants
- K121791Zou Anterior Lumbar Plate SystemCorelink, LLC · 2012 · 2 generations on113descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033312 | Ebi Top Loading Mas Spinal Fixation System | Ebi, L.P. | 2004 | — |
| +1 | K090523 | Polaris Spinal System | 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 | — |
| +1 | K082187 | Biomet Anterior Lumbar Plate | Ebi, L.P. | 2008 | — |
| +2 | K121791 | Zou Anterior Lumbar Plate System | Corelink, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 10 | 0 |
| 2015 | 11 | 0 |
| 2016 | 6 | 0 |
| 2017 | 9 | 0 |
| 2018 | 10 | 0 |
| 2019 | 14 | 0 |
| 2020 | 24 | 0 |
| 2021 | 18 | 0 |
| 2022 | 22 | 0 |
| 2023 | 29 | 0 |
| 2024 | 34 | 0 |
| 2025 | 35 | 0 |
| 2026 | 28 | 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 |
|---|---|---|---|
| * | — | Webb-Morley Spine System Named without a submission number | |
| * | — | EBI Omega21 Spinal Fixation Device Named without a submission number | |
| * | — | EBI P148 Spinal Fixation Devcie Named without a submission number | |
| * | — | Zielke VDS System Named without a submission number |
What descends from it? (277)
See all 2775 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, K090523 (Ebi, L.P., 2009) has gone furthest, with 156 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 EBI® Top Loading MAS 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…
Read the full statement (101 words)
The EBI® Top Loading MAS 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033312 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033312: Ebi Top Loading Mas 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/K033312
Report an extraction error
Are you the manufacturer?
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