510(k) · Cleared
Cleared5.5 Helical Flange Spinal System, Polaris Components
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 30, 2009 as substantially equivalent to K061441 (Ebi, L.P., 2006) and 4 other predicates after a 184-day review. Its family tree reaches back 2 generations to 2004. 154 later devices descend from it.
- Decided
- Jul 30, 2009
- Review
- 184 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K041449 (2004). 5 ancestors in all, the oldest K011437 (2001). 154 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK041449 Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange…Interpore Cross Intl. · 2004
- 1 generation backK081952 Synergy Spinal System (6.35 Polaris)Biomet Spine · 2008
- This deviceK090203 5.5 Helical Flange Spinal System, Polaris ComponentsEbi, L.P. · 2009
- Descendant · cites it directly · 153 of its ownK100220 Polaris Spinal SystemEbi, L.P. · 2010
- Descendant · 2 generations on · 104 of its ownK103393 Polaris Spinal SystemBiomet Spine · 2011
- Descendant · 3 generations on · 103 of its ownK110906 Apex Spine SystemSpinecraft, LLC · 2011
- Descendant · 4 generations on · 81 of its ownK113058 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · cites it directly · 76 of its ownK111957 Polaris Spinal SystemBiomet Spine (Ebi, LLC) · 2011
Showing 5 of 154 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 154 · See all- K100220Polaris Spinal SystemEbi, L.P. · 2010 · cites it directly153descendants
- K103393Polaris Spinal SystemBiomet Spine · 2011 · 2 generations on104descendants
- K110906Apex Spine SystemSpinecraft, LLC · 2011 · 3 generations on103descendants
- K113058Tiger Spine SystemCorelink, LLC · 2012 · 4 generations on81descendants
- K111957Polaris Spinal SystemBiomet Spine (Ebi, LLC) · 2011 · cites it directly76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction… | Interpore Cross Intl. | 2004 | — |
| −1 | K081952 | Synergy Spinal System (6.35 Polaris) | Biomet Spine | 2008 | — |
| 0 (this device) | K090203 | 5.5 Helical Flange Spinal System, Polaris Components | Ebi, L.P. | 2009 | — |
| +1 | K100220 | Polaris Spinal System | Ebi, L.P. | 2010 | — |
| +2 | K103393 | Polaris Spinal System | Biomet Spine | 2011 | — |
| +3 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| +4 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +1 | K111957 | Polaris Spinal System | Biomet Spine (Ebi, LLC) | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 9 | 0 |
| 2018 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 9 | 0 |
| 2022 | 11 | 0 |
| 2023 | 15 | 0 |
| 2024 | 21 | 0 |
| 2025 | 19 | 0 |
| 2026 | 12 | 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? (5)
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 |
|---|---|---|---|
| * | K061441 | Ebi 5.5 Helical Flange Spinal SystemSummary page 2…cteristics, and principles of operation and do not present any new issues of safety or effectiveness. Examples of predicates include EBI's Helical Flange Spinal Systems (K061441 & K041449), the Synergy Spinal System (KO1 1437 & K081952) and the Array Spinal System (K061563). Based upon the mechanical testi… | 2006 |
| * | K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatSummary page 2…, and principles of operation and do not present any new issues of safety or effectiveness. Examples of predicates include EBI's Helical Flange Spinal Systems (K061441 & K041449), the Synergy Spinal System (KO1 1437 & K081952) and the Array Spinal System (K061563). Based upon the mechanical testing, the 5.… | 2004 |
| * | K011437 | Synergy 4.0 MM, 4.5 MM VLS Screws | 2001 |
| * | K081952 | Synergy Spinal System (6.35 Polaris)Summary page 2…any new issues of safety or effectiveness. Examples of predicates include EBI's Helical Flange Spinal Systems (K061441 & K041449), the Synergy Spinal System (KO1 1437 & K081952) and the Array Spinal System (K061563). Based upon the mechanical testing, the 5.5 Helical Flange Spinal System is substantially… | 2008 |
| * | K061563 | Ebi Array Spinal SystemSummary page 2…ness. Examples of predicates include EBI's Helical Flange Spinal Systems (K061441 & K041449), the Synergy Spinal System (KO1 1437 & K081952) and the Array Spinal System (K061563). Based upon the mechanical testing, the 5.5 Helical Flange Spinal System is substantially equivalent for its intended use to oth… | 2006 |
What descends from it? (154)
See all 1548 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100220 | Polaris Spinal System | 2010 | 153 |
| K111957 | Polaris Spinal System | 2011 | 76 |
| K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | 2013 | 75 |
| K131615 | Polaris Spinal System | 2013 | 70 |
| K133746 | Polaris Spinal System | 2014 | 67 |
| K140123 | Polaris Spinal System -Translation Screw | 2014 | 22 |
| K141804 | Polaris Spinal System - HA Coated | 2014 | 21 |
| K162134 | ENNOVATE Spinal System | 2016 | 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 5 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K100220 (Ebi, L.P., 2010) has gone furthest, with 153 descendants of its own.
- 8 other devices also cite its predicate K061441.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 5.5 Helical Flange Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion 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 and for use with autograft. The device is indicated for all the following indications: degenerative disc disease…
Read the full statement (344 words)
The 5.5 Helical Flange Spinal System is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion 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 and for use with autograft. The device is indicated for all the following indications: 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 lordosis), tumor, stenosis, pseudarthrosis, and failed previous fusion.
The 5.5 Helical Flange Percutaneous Instruments are intended to be used with the 5.5 Polaris implants. The Percutaneous instruments when used with the Percutaneous cannulated screws and percutaneous rods, are indicated to provide the surgeon with a percutaneous approach for posterior spinal surgery for the following indications: 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 lordosis), tumor, stenosis, pseudarthrosis, 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 and for use with autograft.
The 5.5 Helical Flange Spinal System Mini-Open Instruments, when used with the 5.5 Helical Flange Spinal System implants are indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery for the following indications: 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 lordosis), tumor,.stenosis, pseudarthrosis, 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 and for use with autograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090203: 5.5 Helical Flange Spinal System, Polaris Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090203
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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