510(k) · Cleared
Recalled · 2009Ebi 5.5 Helical Flange Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 25, 2006 after a 62-day review. The FDA summary names its predicate without a number. 261 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 25, 2006
- Review
- 62 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 2
- Predicates
- 0
261 later devices descend from it, 9 citing it directly.
- This deviceK061441 Ebi 5.5 Helical Flange Spinal SystemEbi, L.P. · 2006
- Descendant · cites it directly · 255 of its ownK081952 Synergy Spinal System (6.35 Polaris)Biomet Spine · 2008
- Descendant · cites it directly · 156 of its ownK090523 Polaris Spinal SystemEbi, L.P. · 2009
- Descendant · cites it directly · 154 of its ownK090203 5.5 Helical Flange Spinal System, Polaris ComponentsEbi, 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
Showing 5 of 261 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 261 · See all- K081952Synergy Spinal System (6.35 Polaris)Biomet Spine · 2008 · cites it directly255descendants
- K090523Polaris Spinal SystemEbi, L.P. · 2009 · cites it directly156descendants
- K0902035.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P. · 2009 · cites it directly154descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061441 | Ebi 5.5 Helical Flange Spinal System | Ebi, L.P. | 2006 | — |
| +1 | K081952 | Synergy Spinal System (6.35 Polaris) | Biomet Spine | 2008 | — |
| +1 | K090523 | Polaris Spinal System | Ebi, L.P. | 2009 | — |
| +1 | K090203 | 5.5 Helical Flange Spinal System, Polaris Components | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 16 | 0 |
| 2014 | 12 | 0 |
| 2015 | 18 | 0 |
| 2016 | 12 | 0 |
| 2017 | 15 | 0 |
| 2018 | 19 | 0 |
| 2019 | 13 | 0 |
| 2020 | 15 | 0 |
| 2021 | 14 | 0 |
| 2022 | 18 | 0 |
| 2023 | 25 | 0 |
| 2024 | 26 | 0 |
| 2025 | 23 | 0 |
| 2026 | 17 | 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 MNH? 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? (6)
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® Array Spinal Fixation System/EBI® SpineLink II Spinal Fixation system with the… Named without a submission number | |
| * | — | EBI® Array Spinal Fixation System Named without a submission number | |
| * | — | EBI® Webb Morley Spine System Named without a submission number | |
| * | — | Interpore Cross International Synergy™ Spinal System (Posterior) Named without a submission number | |
| * | — | Interpore Cross International Synergy Spinal System (Anterior) Named without a submission number | |
| * | — | Medtronic Sofamor Danek CD HORIZON® Spinal System Named without a submission number |
What descends from it? (261)
See all 2619 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081952 | Synergy Spinal System (6.35 Polaris) | 2008 | 255 |
| K090523 | Polaris Spinal System | 2009 | 156 |
| K090203 | 5.5 Helical Flange Spinal System, Polaris Components | 2009 | 154 |
| K091067 | 5.5 Polaris Spinal System | 2009 | 79 |
| K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | 2013 | 75 |
| K133746 | Polaris Spinal System | 2014 | 67 |
| K140123 | Polaris Spinal System -Translation Screw | 2014 | 22 |
| K121130 | Polaris Spinal System-Ballista Spinal Rods | 2012 | 1 |
| K123451 | Polaris Spinal System - Ballista II Rods | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2009 | Not classified | Z-2300-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
| Apr 2, 2009 | Not classified | Z-2301-2009 | Nonconforming Material/Component | Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081952 (Biomet Spine, 2008) has gone furthest, with 255 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 5.5 Helical Flange 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…
Read the full statement (327 words)
The 5.5 Helical Flange 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, pseudoarthrosis, and failed previous fusion.
The 5.5 Helical Flange Spinal System Percutaneous Instruments, when used with the 5.5 Helical Flange Spinal System cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications, regardless of 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., kyphosis, and lordosis), stenosis, pseudoarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients.
The 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange Spiral System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications, regardless of 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., kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and failed previous fusion that warrant the use of a non-cervical spinal fixation device intended for use as a pedicle screw fixation system or sacral/iliac screw fixation system. Pedicle screw fixation is limited to skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061441 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061441: Ebi 5.5 Helical Flange Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061441
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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