510(k) · Cleared
ClearedPolaris Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine (Ebi, LLC) · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Aug 19, 2011 as substantially equivalent to K090203 (Ebi, L.P., 2009) and 2 other predicates after a 39-day review. Its family tree reaches back 8 generations to 1995. 76 later devices descend from it.
- Decided
- Aug 19, 2011
- Review
- 39 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K950697 (1995). 68 ancestors in all, the oldest K901587 (1990). 76 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 7 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 6 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 5 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 4 generations backK060979 Xia Titanium and 4.5 Spinal SystemsStryker Spine · 2006
- 3 generations backK082942 Modfication to: Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK090230 Expedium Spine SystemDepuy Spine, Inc. · 2009
- 1 generation backK091067 5.5 Polaris Spinal SystemBiomet Spine · 2009
- This deviceK111957 Polaris Spinal SystemBiomet Spine (Ebi, LLC) · 2011
- Descendant · cites it directly · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- Descendant · 2 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
- Descendant · 3 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
- Descendant · 4 generations on · 26 of its ownK150856 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · cites it directly75descendants
- K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on70descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
- K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 3 generations on30descendants
- K150856Reform Pedicle Screw SystemPrecision Spine, Inc. · 2015 · 4 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −7 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −6 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −5 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −4 | K060979 | Xia Titanium and 4.5 Spinal Systems | Stryker Spine | 2006 | — |
| −3 | K082942 | Modfication to: Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K090230 | Expedium Spine System | Depuy Spine, Inc. | 2009 | — |
| −1 | K091067 | 5.5 Polaris Spinal System | Biomet Spine | 2009 | — |
| 0 (this device) | K111957 | Polaris Spinal System | Biomet Spine (Ebi, LLC) | 2011 | — |
| +1 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| +2 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| +2 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
| +3 | K143248 | Reform Pedicle Screw System | Precision Spine, Inc. | 2014 | — |
| +4 | K150856 | Reform Pedicle Screw System | Precision Spine, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 8 | 0 |
| 2026 | 8 | 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? (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 |
|---|---|---|---|
| * | K090203 | 5.5 Helical Flange Spinal System, Polaris ComponentsSummary page 2…multiaxial and fixed titanium screws and CoCr rods in the Polaris Spinal System are substantially equivalent to the other components in Polaris Spinal System cleared in K090203, K091067and K100220. These screws and rods are substantially equivalent to the predicates with respect to intended use and indica… | 2009 |
| * | K091067 | 5.5 Polaris Spinal SystemSummary page 2…al and fixed titanium screws and CoCr rods in the Polaris Spinal System are substantially equivalent to the other components in Polaris Spinal System cleared in K090203, K091067and K100220. These screws and rods are substantially equivalent to the predicates with respect to intended use and indications, te… | 2009 |
| * | K100220 | Polaris Spinal SystemSummary page 2…d titanium screws and CoCr rods in the Polaris Spinal System are substantially equivalent to the other components in Polaris Spinal System cleared in K090203, K091067and K100220. These screws and rods are substantially equivalent to the predicates with respect to intended use and indications, technological… | 2010 |
What descends from it? (76)
See all 762 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?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 5 months on median.
- 4 of the 68 ancestors have a recall of any class.
- Of its descendants, K123549 (Biomet Spine (Aka Ebi, LLC), 2013) has gone furthest, with 75 descendants of its own.
- 7 other devices also cite its predicate K090203.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. The device is indicated for all the following indications…
Read the full statement (318 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 anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients and for use with autograft and/or allograft. 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/or lordosis), tumor, stenosis, pseudoarthrosis, or failed previous fusion.
The Ballista instruments are intended to be used with Ballista/Polaris 5.5mm implants. Cannulated screws and percutaneous rods may be used with the Ballista instruments 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/or lordosis), tumor, stenosis, pseudoarthrosis, or 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 and/or allograft.
The Polaris Spinal System may be used with the instruments in the AccuVision Minimally Invasive Spinal Exposure System to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The dominos in the Polaris Spinal System can be used to connect the Polaris Spinal System to the Altius Spinal System, The Array Spinal System, the Biomet Omega21 Spinal System, or the Synergy Spinal System to achieve additional levels of fixation. Please refer to the individual system's Package Insert for a list of the indications for use for each system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111957: 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/K111957
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