510(k) · Cleared
ClearedPolaris Spinal 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 1, 2009 as substantially equivalent to K081952 (Biomet Spine, 2008) and 6 other predicates after a 125-day review. Its family tree reaches back 2 generations to 1990. 156 later devices descend from it.
- Decided
- Jul 1, 2009
- Review
- 125 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 2 generations to K901587 (1990). 16 ancestors in all. 156 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 1 generation backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- This deviceK090523 Polaris Spinal SystemEbi, L.P. · 2009
- Descendant · cites it directly · 153 of its ownK100220 Polaris Spinal SystemEbi, L.P. · 2010
- Descendant · cites it directly · 144 of its ownK100409 Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation…Biomet Spine (Aka Ebi, LLC) · 2010
- Descendant · cites it directly · 104 of its ownK103393 Polaris Spinal SystemBiomet Spine · 2011
- Descendant · cites it directly · 104 of its ownK100438 Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation…Ebi, L.P. · 2010
- Descendant · 2 generations on · 103 of its ownK110906 Apex Spine SystemSpinecraft, LLC · 2011
Showing 5 of 156 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 156 · See all- K100220Polaris Spinal SystemEbi, L.P. · 2010 · cites it directly153descendants
- K100409Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemBiomet Spine (Aka Ebi, LLC) · 2010 · cites it directly144descendants
- K103393Polaris Spinal SystemBiomet Spine · 2011 · cites it directly104descendants
- K100438Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemEbi, L.P. · 2010 · cites it directly104descendants
- K110906Apex Spine SystemSpinecraft, LLC · 2011 · 2 generations on103descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −1 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| 0 (this device) | K090523 | Polaris Spinal System | Ebi, L.P. | 2009 | — |
| +1 | K100220 | Polaris Spinal System | Ebi, L.P. | 2010 | — |
| +1 | K100409 | Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System | Biomet Spine (Aka Ebi, LLC) | 2010 | — |
| +1 | K103393 | Polaris Spinal System | Biomet Spine | 2011 | — |
| +1 | K100438 | Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation System | Ebi, L.P. | 2010 | — |
| +2 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 3 | 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? (8)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081952 | Synergy Spinal System (6.35 Polaris)Summary page 2…characteristics, and principles of operation and do not present any new issues of safety or effectiveness. Examples of predicates include Helical Flange Spinal Syste m .(K081952, K06144land K041449), the Synergy Spinal System (KO0 143, K950709 & K950099) and the Array Spinal System (K033312 & K061563.) Bas… | 2008 |
| * | K061441 | Ebi 5.5 Helical Flange Spinal System | 2006 |
| * | K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatSummary page 2…principles of operation and do not present any new issues of safety or effectiveness. Examples of predicates include Helical Flange Spinal Syste m .(K081952, K06144land K041449), the Synergy Spinal System (KO0 143, K950709 & K950099) and the Array Spinal System (K033312 & K061563.) Based upon the mechanic… | 2004 |
| Kept off the family tree | K001143 | FDA’s K001143 is Release NF Antibacterial Foley Catheter, Antibacterial Personal Catheter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2000 |
| * | K950709 | Synergy TI Anterior Spinal SystemSummary page 2…y new issues of safety or effectiveness. Examples of predicates include Helical Flange Spinal Syste m .(K081952, K06144land K041449), the Synergy Spinal System (KO0 143, K950709 & K950099) and the Array Spinal System (K033312 & K061563.) Based upon the mechanical testing, the Polaris Spinal System is subst… | 1995 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 2…es of safety or effectiveness. Examples of predicates include Helical Flange Spinal Syste m .(K081952, K06144land K041449), the Synergy Spinal System (KO0 143, K950709 & K950099) and the Array Spinal System (K033312 & K061563.) Based upon the mechanical testing, the Polaris Spinal System is substantially e… | 1997 |
| * | K033312 | Ebi Top Loading Mas Spinal Fixation SystemSummary page 2…s of predicates include Helical Flange Spinal Syste m .(K081952, K06144land K041449), the Synergy Spinal System (KO0 143, K950709 & K950099) and the Array Spinal System (K033312 & K061563.) Based upon the mechanical testing, the Polaris Spinal System is substantially equivalent for its intended use to othe… | 2004 |
| * | K061563 | Ebi Array Spinal SystemSummary page 2…cates include Helical Flange Spinal Syste m .(K081952, K06144land K041449), the Synergy Spinal System (KO0 143, K950709 & K950099) and the Array Spinal System (K033312 & K061563.) Based upon the mechanical testing, the Polaris Spinal System is substantially equivalent for its intended use to other spinal s… | 2006 |
What descends from it? (156)
See all 1565 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 |
| K100409 | Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation System | 2010 | 144 |
| K103393 | Polaris Spinal System | 2011 | 104 |
| K100438 | Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation System | 2010 | 104 |
| K133746 | Polaris Spinal System | 2014 | 67 |
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 19 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K100220 (Ebi, L.P., 2010) has gone furthest, with 153 descendants of its own.
- 5 other devices also cite its predicate K081952.
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 Polaris 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 fir all the following indications: degenerative disc disease (defined as…
Read the full statement (332 words)
The Polaris 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 fir 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 Ballista instruments are intended to be used with the 5.5 Polaris implants. The Ballista instruments when used with the Ballista 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,lseudarthrosis, 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 Accuvision Instruments, when used with the Polaris 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/K090523 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090523: Polaris Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090523
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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