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 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 2, 2011 as substantially equivalent to K090523 (Ebi, L.P., 2009) and 4 other predicates after a 75-day review. Its family tree reaches back 4 generations to 1990. 104 later devices descend from it.
- Decided
- Feb 2, 2011
- Review
- 75 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K901587 (1990). 20 ancestors in all. 104 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 3 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 2 generations backK090523 Polaris Spinal SystemEbi, L.P. · 2009
- 1 generation backK100220 Polaris Spinal SystemEbi, L.P. · 2010
- This deviceK103393 Polaris Spinal SystemBiomet Spine · 2011
- Descendant · cites it directly · 103 of its ownK110906 Apex Spine SystemSpinecraft, LLC · 2011
- Descendant · 2 generations on · 81 of its ownK113058 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · 3 generations on · 40 of its ownK131250 Tiger Spine SystemCorelink, LLC · 2013
- Descendant · 3 generations on · 30 of its ownK151977 icotec Pedicle SystemIcotec AG · 2016
- Descendant · 3 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 104 · See all- K110906Apex Spine SystemSpinecraft, LLC · 2011 · cites it directly103descendants
- K113058Tiger Spine SystemCorelink, LLC · 2012 · 2 generations on81descendants
- K131250Tiger Spine SystemCorelink, LLC · 2013 · 3 generations on40descendants
- K151977icotec Pedicle SystemIcotec AG · 2016 · 3 generations on30descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −3 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −2 | K090523 | Polaris Spinal System | Ebi, L.P. | 2009 | — |
| −1 | K100220 | Polaris Spinal System | Ebi, L.P. | 2010 | — |
| 0 (this device) | K103393 | Polaris Spinal System | Biomet Spine | 2011 | — |
| +1 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| +2 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +3 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| +3 | K151977 | icotec Pedicle System | Icotec AG | 2016 | — |
| +3 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
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 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 13 | 0 |
| 2024 | 18 | 0 |
| 2025 | 16 | 0 |
| 2026 | 10 | 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 KWQ? 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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 |
|---|---|---|---|
| * | K090523 | Polaris Spinal SystemSummary page 2…ivalence: The 6.35 titanium uniplanar screws in the Polaris Spinal System are substantially equivalent to the oilier screws in Polaris Spinal System cleared in K090523, K01 1437, K04 1449 K08 1952 and K100220.These new screws are substantially equivalent to the predicate screws with respect… | 2009 |
| * | K011437 | Synergy 4.0 MM, 4.5 MM VLS ScrewsSummary page 2…The 6.35 titanium uniplanar screws in the Polaris Spinal System are substantially equivalent to the oilier screws in Polaris Spinal System cleared in K090523, K01 1437, K04 1449 K08 1952 and K100220.These new screws are substantially equivalent to the predicate screws with respect to in… | 2001 |
| * | K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatSummary page 2…6.35 titanium uniplanar screws in the Polaris Spinal System are substantially equivalent to the oilier screws in Polaris Spinal System cleared in K090523, K01 1437, K04 1449 K08 1952 and K100220.These new screws are substantially equivalent to the predicate screws with respect to intended use… | 2004 |
| * | K081952 | Synergy Spinal System (6.35 Polaris)Summary page 2…nium uniplanar screws in the Polaris Spinal System are substantially equivalent to the oilier screws in Polaris Spinal System cleared in K090523, K01 1437, K04 1449 K08 1952 and K100220.These new screws are substantially equivalent to the predicate screws with respect to intended use and indi… | 2008 |
| * | K100220 | Polaris Spinal SystemSummary page 2…ews in the Polaris Spinal System are substantially equivalent to the oilier screws in Polaris Spinal System cleared in K090523, K01 1437, K04 1449 K08 1952 and K100220.These new screws are substantially equivalent to the predicate screws with respect to intended use and indications, technolo… | 2010 |
What descends from it? (104)
See all 1041 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110906 | Apex Spine System | 2011 | 103 |
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 21 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K110906 (Spinecraft, LLC, 2011) has gone furthest, with 103 descendants of its own.
- 4 other devices also cite its predicate K090523.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
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 for all the following indications: degenerative disc disease (defined as…
Read the full statement (394 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 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 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, 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. Pedicie screw fixation is limited to skeletally mature patients and for use with autograft.
The Accuision 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.
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 Omega2 I 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/K103393 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103393: 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/K103393
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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